Trial Outcomes & Findings for CMP-001 for Relapsed and Refractory Lymphoma (NCT NCT03983668)
NCT ID: NCT03983668
Last Updated: 2026-03-30
Results Overview
To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
From the start of treatment up to two years
Results posted on
2026-03-30
Participant Flow
No participants were enrolled in Phase II as the study terminated prior to initiation of Phase II.
Participant milestones
| Measure |
CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
9
|
2
|
|
Overall Study
COMPLETED
|
1
|
8
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
|---|---|---|---|
|
Overall Study
Disease progression
|
2
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
CMP-001 for Relapsed and Refractory Lymphoma
Baseline characteristics by cohort
| Measure |
CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort
n=3 Participants
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort
n=9 Participants
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort
n=2 Participants
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=4 Participants
|
4 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
9 Participants
n=38 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
5 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=38 Participants
|
|
Age, Continuous
|
54 years
n=4 Participants
|
65 years
n=28 Participants
|
50 years
n=10 Participants
|
60 years
n=38 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
2 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
7 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=4 Participants
|
8 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
12 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=38 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=4 Participants
|
9 participants
n=28 Participants
|
2 participants
n=10 Participants
|
14 participants
n=38 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment up to two yearsPopulation: Participants enrolled to each dose cohort for the Phase I portion of the study (5mg, 7.5mg, 10mg)
To examine the toxicity related to the therapy by measuring the number of treatment related adverse events in patients
Outcome measures
| Measure |
CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort
n=3 Participants
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort
n=9 Participants
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort
n=2 Participants
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities Using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From the start of treatment up to two yearsPopulation: Participants who received at least 1 dose of CMP-001 and at least 1 recorded post-baseline assessment of objective response, assessed according to Cheson 2007 criteria
Objective response rate (ORR) will be assessed by CT or PET-CT scans (with calipers for superficial cutaneous tumors) at Screening and at scheduled follow-up visits. The same imaging modality used at baseline will be used throughout the study when possible. Antitumor activity will be evaluated according to Cheson 2007 criteria. ORR defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort
n=3 Participants
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort
n=9 Participants
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort
n=2 Participants
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
|---|---|---|---|
|
Objective Response Rate (ORR)
Progressive Disease (PD)
|
2 participants
|
1 participants
|
2 participants
|
|
Objective Response Rate (ORR)
Complete Response (CR)
|
1 participants
|
3 participants
|
0 participants
|
|
Objective Response Rate (ORR)
Partial Response (PR)
|
0 participants
|
2 participants
|
0 participants
|
|
Objective Response Rate (ORR)
Stable Disease (SD)
|
0 participants
|
3 participants
|
0 participants
|
Adverse Events
CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort
n=3 participants at risk
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort
n=9 participants at risk
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort
n=2 participants at risk
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
|---|---|---|---|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
Other adverse events
| Measure |
CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort
n=3 participants at risk
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort
n=9 participants at risk
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort
n=2 participants at risk
Participants receive CMP-001 by intratumoral injection weekly for seven weeks. Doses are then given every 3 weeks (i.e., Week 7, Week 10, Week 13, etc.) until a subject experiences unacceptable toxicities and, in the Investigator's opinion, continued treatment is not in his or her best interest. Pembrolizumab, 200 mg, will be given by IV infusion every 3 weeks, starting on Week 1, Day 1.
Intratumoral administration of CMP-001 and intravenous administration of pembrolizumab
CMP-001: Immunostimulatory therapeutic agent
Pembrolizumab: Humanized antibody used in cancer immunotherapy
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
33.3%
3/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
44.4%
4/9 • Number of events 8 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 13 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
44.4%
4/9 • Number of events 5 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Chills
|
33.3%
1/3 • Number of events 9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Edema limbs
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
33.3%
3/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Fatigue
|
66.7%
2/3 • Number of events 6 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
77.8%
7/9 • Number of events 21 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Fever
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
33.3%
3/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Flu like symptoms
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Injection site reaction
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Localized edema
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
General disorders and administration site conditions
Pain
|
33.3%
1/3 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
44.4%
4/9 • Number of events 9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Immune system disorders
Allergic reaction
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
77.8%
7/9 • Number of events 52 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
33.3%
3/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
33.3%
3/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 7 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 5 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 8 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
Weight loss
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
33.3%
3/9 • Number of events 13 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
44.4%
4/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 7 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
44.4%
4/9 • Number of events 7 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
44.4%
4/9 • Number of events 18 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 7 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 8 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
55.6%
5/9 • Number of events 6 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
33.3%
1/3 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 10 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
33.3%
3/9 • Number of events 8 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Psychiatric disorders
Agitation
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Psychiatric disorders
Restlessness
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Renal and urinary disorders
Urinary urgency
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
44.4%
4/9 • Number of events 5 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
44.4%
4/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 4 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
33.3%
3/9 • Number of events 3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
22.2%
2/9 • Number of events 5 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
11.1%
1/9 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 2 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
0.00%
0/9 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
50.0%
1/2 • Number of events 1 • All AEs from Week 1 Day 1 (treatment initiation) through 30 days following cessation of study treatment must be reported by the investigator, up to 25 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place