Trial Outcomes & Findings for Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma (NCT NCT00807495)
NCT ID: NCT00807495
Last Updated: 2018-03-27
Results Overview
Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years)
Results posted on
2018-03-27
Participant Flow
Participants took part in the study at 12 investigative sites in the United States from 10 February 2009 to last participant off study 13 February 2013, with a data cut-off on 04 January 2011 to report the primary endpoint.
Participants with a diagnosis of Aggressive Non-Hodgkin's Lymphoma received 50 mg alisertib twice daily for 7 days in 21 day cycles. Results are categorized as disease sub-types: Diffuse Large B-cell lymphoma (DLBL), Mantle Cell lymphoma (MCL), Transformed Follicular lymphoma (TFL), Burkitts lymphoma (BL) and Aggressive T-Cell lymphoma (ATL).
Participant milestones
| Measure |
Alisertib 50 mg BID Starting Dose (DLBL)
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (TFL)
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
13
|
5
|
1
|
7
|
|
Overall Study
COMPLETED
|
14
|
7
|
1
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
4
|
1
|
5
|
Reasons for withdrawal
| Measure |
Alisertib 50 mg BID Starting Dose (DLBL)
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (TFL)
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Patient
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Reason Not Specified
|
0
|
3
|
2
|
0
|
3
|
Baseline Characteristics
Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Alisertib 50 mg BID Starting Dose (DLBL)
n=22 Participants
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=13 Participants
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (TFL)
n=5 Participants
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 Participants
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=7 Participants
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 11.11 • n=5 Participants
|
67.2 years
STANDARD_DEVIATION 6.71 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
76.0 years
STANDARD_DEVIATION NA • n=4 Participants
|
54.4 years
STANDARD_DEVIATION 16.90 • n=21 Participants
|
65.1 years
STANDARD_DEVIATION 11.56 • n=10 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
21 participants
n=5 Participants
|
13 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
47 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
21 participants
n=5 Participants
|
13 participants
n=7 Participants
|
4 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
45 participants
n=10 Participants
|
|
Weight
|
88.85 kg
STANDARD_DEVIATION 27.022 • n=5 Participants
|
96.18 kg
STANDARD_DEVIATION 25.139 • n=7 Participants
|
89.06 kg
STANDARD_DEVIATION 29.724 • n=5 Participants
|
72.58 kg
STANDARD_DEVIATION NA • n=4 Participants
|
84.45 kg
STANDARD_DEVIATION 14.494 • n=21 Participants
|
89.88 kg
STANDARD_DEVIATION 24.737 • n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years)Population: Safety population was defined as all participants who received any amount of alisertib. Efficacy analysis for the response-evaluable population is a subset of the safety population, with participants having a minimum of baseline imaging and one on-study imaging.
Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria).
Outcome measures
| Measure |
Alisertib 50 mg BID Starting Dose (TFL)
n=5 Participants
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 Participants
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=6 Participants
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=13 Participants
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (DLBL)
n=16 Participants
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Best Overall Response Rate Based on Investigator's Assessment (Applying the IWG 2007 Response Criteria)
|
40 percentage of participants
|
100 percentage of participants
|
50 percentage of participants
|
23 percentage of participants
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)Population: Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. Here number of participants analyzed were participants with PD. TTP was censored at the last response assessment that was SD or better.
Time to progression (TTP) is defined as the time in days from the date of first study drug administration to the date of first documentation of Progressive Disease (PD) according to IWG criteria (Cheson 2007). PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
Outcome measures
| Measure |
Alisertib 50 mg BID Starting Dose (TFL)
n=5 Participants
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 Participants
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=6 Participants
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=13 Participants
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (DLBL)
n=16 Participants
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Time to Progression (TTP)
|
NA days
Median was not reached due to the low number of participants with events.
|
NA days
Median was not reached due to the low number of participants with events.
|
237.0 days
Interval 46.0 to 631.0
|
139.0 days
Interval 48.0 to 809.0
|
84.0 days
Interval 48.0 to 430.0
|
SECONDARY outcome
Timeframe: Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)Population: Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. For a participant who had not progressed and had not died, PFS was censored at the last response assessment that was SD or better.
PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death.
Outcome measures
| Measure |
Alisertib 50 mg BID Starting Dose (TFL)
n=5 Participants
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 Participants
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=6 Participants
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=13 Participants
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (DLBL)
n=16 Participants
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
NA days
Median was not reached due to the low number of participants with events.
|
NA days
Median was not reached due to the low number of participants with events.
|
237.0 days
Interval 46.0 to 631.0
|
139.0 days
Interval 48.0 to 809.0
|
84.0 days
Interval 48.0 to 364.0
|
SECONDARY outcome
Timeframe: Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)Population: Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. All responders were evaluated in this outcome measure. Participants who had not progressed, DOR was censored at last response assessment that was SD or better.
DOR is defined as the time from the date of first documentation of a CR, or partial response (PR) to the date of first documentation of PD according to IWG criteria. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir, as described in the IWG response criteria (Cheson 2007).
Outcome measures
| Measure |
Alisertib 50 mg BID Starting Dose (TFL)
n=2 Participants
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 Participants
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=3 Participants
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=3 Participants
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (DLBL)
n=4 Participants
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
NA days
Median was not reached due to the low number of participants with events.
|
NA days
Median was not reached due to the low number of participants with events.
|
596.0 days
Interval 202.0 to 596.0
|
646.0 days
Interval 243.0 to 646.0
|
454.0 days
Interval 182.0 to 565.0
|
SECONDARY outcome
Timeframe: First dose of study drug to 30 days after last dose (Up to 25 months)Population: Safety population was defined as all participants who received any amount of alisertib.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and includes all-causality (ie, treatment-related and not treatment-related as assessed by the investigator).
Outcome measures
| Measure |
Alisertib 50 mg BID Starting Dose (TFL)
n=5 Participants
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 Participants
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=7 Participants
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=13 Participants
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (DLBL)
n=22 Participants
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
5 participants
|
1 participants
|
7 participants
|
13 participants
|
22 participants
|
SECONDARY outcome
Timeframe: First dose of study drug to 30 days after last dose (Up to 25 months)Population: Safety population was defined as all participants who received any amount of alisertib.
Vital signs (blood pressure, heart rate, and oral temperature) measurements were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Alisertib 50 mg BID Starting Dose (TFL)
n=5 Participants
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 Participants
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=7 Participants
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=13 Participants
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (DLBL)
n=22 Participants
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Pyrexia
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
7 participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Hypotension
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
6 participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Weight decreased
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Tachycardia
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Hypertension
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Bradycardia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Cardiac flutter
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: First dose of study drug to 30 days after last dose (Up to 25 months)Population: Safety population was defined as all participants who received any amount of alisertib.
Abnormal laboratory values for chemistry or hematology tests that were assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4). A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Alisertib 50 mg BID Starting Dose (TFL)
n=5 Participants
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 Participants
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=7 Participants
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=13 Participants
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (DLBL)
n=22 Participants
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Thrombocytopenia
|
3 participants
|
1 participants
|
5 participants
|
5 participants
|
11 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Alanine aminotransferase increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
6 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Aspartate aminotransferase increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
6 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Blood alkaline phosphatase increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
6 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Hypokalaemia
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Blood lactate dehydrogenase increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Blood creatinine increased
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Blood potassium decreased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Lymphopenia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Blood urea increased
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Hypercalcaemia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Hypernatraemia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Hypophosphataemia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Mean cell volume increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Urine colour abnormal
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Neutropenia
|
3 participants
|
1 participants
|
4 participants
|
9 participants
|
13 participants
|
Adverse Events
Alisertib 50 mg BID Starting Dose (DLBL)
Serious events: 16 serious events
Other events: 22 other events
Deaths: 0 deaths
Alisertib 50 mg BID Starting Dose (MCL)
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Alisertib 50 mg BID Starting Dose (TFL)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Alisertib 50 mg BID Starting Dose (BL)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Alisertib 50 mg BID Starting Dose (ATL)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alisertib 50 mg BID Starting Dose (DLBL)
n=22 participants at risk
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=13 participants at risk
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (TFL)
n=5 participants at risk
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 participants at risk
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=7 participants at risk
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
27.3%
6/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sepsis
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
18.2%
4/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Multi-organ failure
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Mucosal haemorrhage
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Balance disorder
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Confusional state
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Calculus ureteric
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Ejection fraction decreased
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Death
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Alisertib 50 mg BID Starting Dose (DLBL)
n=22 participants at risk
Participants with diffuse large B-Cell lymphoma (DLBL) received alisertib 50 mg, capsules, orally, twice daily (BID) for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (MCL)
n=13 participants at risk
Participants with mantle cell lymphoma (MCL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (TFL)
n=5 participants at risk
Participants with transformed follicular lymphoma (TFL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (BL)
n=1 participants at risk
Participants with Burkitts lymphoma (BL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
Alisertib 50 mg BID Starting Dose (ATL)
n=7 participants at risk
Participants with aggressive T-Cell lymphoma (ATL) received alisertib 50 mg, capsules, orally, BID for 7 days, followed by 14-day rest period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 24 months).
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
72.7%
16/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
69.2%
9/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
80.0%
4/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
57.1%
4/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
68.2%
15/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
53.8%
7/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
60.0%
3/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
71.4%
5/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
59.1%
13/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
61.5%
8/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
60.0%
3/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
57.1%
4/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
45.5%
10/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
38.5%
5/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
60.0%
3/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
71.4%
5/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
63.6%
14/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
61.5%
8/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
60.0%
3/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
31.8%
7/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
40.0%
2/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
6/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
57.1%
4/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
22.7%
5/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
23.1%
3/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
57.1%
4/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.7%
5/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
27.3%
6/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ascites
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
54.5%
12/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
69.2%
9/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
80.0%
4/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
85.7%
6/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
22.7%
5/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
40.0%
2/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
18.2%
4/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
27.3%
6/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Catheter site erythema
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.9%
9/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
61.5%
8/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
80.0%
4/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
23.1%
3/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
40.9%
9/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
30.8%
4/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
40.0%
2/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
71.4%
5/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
60.0%
3/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Sinus headache
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Syncope
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Tremor
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Sedation
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
4/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
40.0%
2/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
27.3%
6/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
27.3%
6/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
27.3%
6/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count decreased
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Haemoglobin decreased
|
18.2%
4/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood potassium decreased
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Investigations
Urine colour abnormal
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.8%
7/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
30.8%
4/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral candidiasis
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Fungal skin infection
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Localised infection
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Eye infection
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
30.8%
4/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Confusional state
|
13.6%
3/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Attention deficit
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
27.3%
6/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
40.0%
2/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Vision blurred
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Night blindness
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Memory Impairment
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
23.1%
3/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster
|
4.5%
1/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
15.4%
2/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
7.7%
1/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
2/22 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/13 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study drug to 30 days after last dose (Up to 25 Months)
The investigator documents any occurrence of adverse events including abnormal laboratory findings. Additionally, any event spontaneously reported by the participant or observed by the investigator are recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER