Trial Outcomes & Findings for Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS (NCT NCT02706899)
NCT ID: NCT02706899
Last Updated: 2019-02-12
Results Overview
A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2019-02-12
Participant Flow
Participant milestones
| Measure |
33A (5 mcg/kg) + Azacitidine
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
33A (10 mcg/kg) + Azacitidine
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
| Measure |
33A (5 mcg/kg) + Azacitidine
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
33A (10 mcg/kg) + Azacitidine
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
8
|
0
|
|
Overall Study
Study Termination by Sponsor
|
4
|
6
|
Baseline Characteristics
Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
Baseline characteristics by cohort
| Measure |
33A (5 mcg/kg) + Azacitidine
n=13 Participants
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
33A (10 mcg/kg) + Azacitidine
n=6 Participants
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
66 years
n=7 Participants
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0: Normal activity
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1: Symptoms but ambulatory
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2: In bed less than 50% of the time
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearA recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.
Outcome measures
| Measure |
33A (5 mcg/kg) + Azacitidine
n=13 Participants
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
33A (10 mcg/kg) + Azacitidine
n=6 Participants
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
|---|---|---|
|
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
Vadastuximab talirine dosed reduced
|
4 Number of doses
|
1 Number of doses
|
|
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
Azacitidine doses delayed
|
3 Number of doses
|
3 Number of doses
|
|
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
Azacitidine doses reduced
|
2 Number of doses
|
2 Number of doses
|
|
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
Azacitidine unplanned dose adjustments
|
3 Number of doses
|
0 Number of doses
|
|
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
Vadastuximab talirine doses delayed
|
2 Number of doses
|
0 Number of doses
|
PRIMARY outcome
Timeframe: N/A - End point not assessedPopulation: No patients were assessed for this outcomes as the study did not progress to Phase 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearAs defined by the number of participants with adverse events and laboratory abnormalities. Participants are included only once per row, even if the participant experienced multiple events applicable to the category.
Outcome measures
| Measure |
33A (5 mcg/kg) + Azacitidine
n=13 Participants
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
33A (10 mcg/kg) + Azacitidine
n=6 Participants
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
|---|---|---|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Treatment-emergent adverse event (TEAE)
|
13 Participants
|
6 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Vadatuximab talirine-related TEAE
|
9 Participants
|
6 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Azacitidine-related TEAE
|
13 Participants
|
6 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Serious TEAE
|
9 Participants
|
4 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Vadatuximab talirine-related serious TEAE
|
4 Participants
|
4 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Azacitidine-related serious TEAE
|
5 Participants
|
4 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
TEAE of Grades 3-5
|
12 Participants
|
6 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Vadatuximab talirine-related TEAE of Grades 3-5
|
9 Participants
|
6 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Azacitidine-related TEAE of Grades 3-5
|
10 Participants
|
6 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
Dose-limiting toxicity
|
2 Participants
|
0 Participants
|
|
Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
TEAE with outcome of death
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: N/A - End point not assessedPopulation: No patients were assessed for this outcomes as the study did not progress to Phase 2.
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the CR rate, as defined by the 2006 IWG criteria for MDS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: N/A - End point not assessedPopulation: No patients were assessed for this outcomes as the study did not progress to Phase 2.
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the HI rate, as defined by the 2006 IWG criteria for MDS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: N/A - End point not assessedPopulation: No patients were assessed for this outcomes as the study did not progress to Phase 2.
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first observation of response (CR, PR, or Marrow CR) to disease progression/relapse or death from any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: N/A - End point not assessedPopulation: No patients were assessed for this outcomes as the study did not progress to Phase 2.
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: N/A - End point not assessedPopulation: No patients were assessed for this outcomes as the study did not progress to Phase 2.
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the rate of transformation to AML after initiation of study therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: N/A - End point not assessedPopulation: No patients were assessed for this outcomes as the study did not progress to Phase 2.
Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to death due to any cause.
Outcome measures
Outcome data not reported
Adverse Events
33A (5 mcg/kg) + Azacitidine
Serious events: 9 serious events
Other events: 13 other events
Deaths: 8 deaths
33A (10 mcg/kg) + Azacitidine
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
33A (5 mcg/kg) + Azacitidine
n=13 participants at risk
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
33A (10 mcg/kg) + Azacitidine
n=6 participants at risk
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
30.8%
4/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
66.7%
4/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Pneumonia
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Cellulitis
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
Other adverse events
| Measure |
33A (5 mcg/kg) + Azacitidine
n=13 participants at risk
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
33A (10 mcg/kg) + Azacitidine
n=6 participants at risk
Vadastuximab talirine (33A) plus azacitidine
Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks
Azacitidine (75 mg/m\^2) given intravenously or subcutaneously x 7 days every 4 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
61.5%
8/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
66.7%
4/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
46.2%
6/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
66.7%
4/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
50.0%
3/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
23.1%
3/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
33.3%
2/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Glossodynia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
46.2%
6/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
66.7%
4/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
38.5%
5/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.1%
3/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Fatigue
|
46.2%
6/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
50.0%
3/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Pyrexia
|
23.1%
3/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
33.3%
2/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
50.0%
3/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Asthenia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Catheter site rash
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Chest discomfort
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Face oedema
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Injection site erythema
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Injection site rash
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Injection site reaction
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Localised oedema
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Oedema peripheral
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
General disorders
Peripheral swelling
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.8%
4/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.1%
3/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
33.3%
2/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
3/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
50.0%
3/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
50.0%
3/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Dizziness
|
23.1%
3/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
50.0%
3/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
33.3%
2/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Intercranial aneurysm
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
50.0%
3/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
83.3%
5/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
66.7%
4/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
33.3%
2/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Blood creatinine increased
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Amylase increased
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Blood urea increased
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Heart rate irregular
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Intraocular pressure increased
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Lipase increased
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Investigations
Protein total decreased
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.5%
5/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
30.8%
4/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Pneumonia
|
23.1%
3/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Rash pustular
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
33.3%
2/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Folliculitis
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Cellulitis
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Nail infection
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Parotitis
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Skin candida
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
33.3%
2/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Eye disorders
Vision blurred
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Eye disorders
Cataract
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Eye disorders
Corneal opacity
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Eye disorders
Photophobia
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
16.7%
1/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.7%
1/13 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
0.00%
0/6 • Up to 1 year
Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60