Trial Outcomes & Findings for Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1)) (NCT NCT00111813)
NCT ID: NCT00111813
Last Updated: 2015-05-21
Results Overview
Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity. Progressive disease was defined as: * \>25% increase in the level of serum monoclonal paraprotein. * 25% increase in 24-hour urinary light chain excretion. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy. * Development of new bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia. Intolerable toxicity was based on the clinical judgment of the investigator.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Day 1 to an event causing discontinuation from the study, assessed up to 29 months
Results posted on
2015-05-21
Participant Flow
Participant milestones
| Measure |
Vorinostat 200 mg + Bortezomib 0.7 mg/m^2
Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
10
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
10
|
5
|
6
|
6
|
Reasons for withdrawal
| Measure |
Vorinostat 200 mg + Bortezomib 0.7 mg/m^2
Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
4
|
2
|
2
|
2
|
|
Overall Study
Progressive disease
|
2
|
1
|
5
|
3
|
4
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
Baseline characteristics by cohort
| Measure |
All Participants
n=34 Participants
Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m\^2, 0.9 mg/m\^2, 1.1 mg/m\^2, or 1.3 mg/m\^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level.
|
|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to an event causing discontinuation from the study, assessed up to 29 monthsEvent causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity. Progressive disease was defined as: * \>25% increase in the level of serum monoclonal paraprotein. * 25% increase in 24-hour urinary light chain excretion. * \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy. * Development of new bone lesions or soft tissue plasmacytomas. * Development of hypercalcemia. Intolerable toxicity was based on the clinical judgment of the investigator.
Outcome measures
| Measure |
All Participants
n=34 Participants
Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m\^2, 0.9 mg/m\^2, 1.1 mg/m\^2, or 1.3 mg/m\^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level.
|
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
|---|---|---|---|---|---|---|
|
Mean Duration of Treatment With Vorinostat
200 mg
|
4.6 Days
Interval 1.0 to 15.0
|
—
|
—
|
—
|
—
|
—
|
|
Mean Duration of Treatment With Vorinostat
300 mg
|
72.6 Days
Interval 28.0 to 210.0
|
—
|
—
|
—
|
—
|
—
|
|
Mean Duration of Treatment With Vorinostat
400 mg
|
107.1 Days
Interval 11.0 to 496.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to disease progression, toxicity, or death, assessed up to 29 monthsAn adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
Outcome measures
| Measure |
All Participants
n=3 Participants
Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m\^2, 0.9 mg/m\^2, 1.1 mg/m\^2, or 1.3 mg/m\^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level.
|
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
n=3 Participants
Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
n=10 Participants
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
No dose modification
|
3 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
One dose modification
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
Two or more dose modifications
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 to disease progression, toxicity, or death, assessed up to 29 monthsAn AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
Outcome measures
| Measure |
All Participants
n=3 Participants
Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m\^2, 0.9 mg/m\^2, 1.1 mg/m\^2, or 1.3 mg/m\^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level.
|
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
n=3 Participants
Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
n=10 Participants
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
|---|---|---|---|---|---|---|
|
Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib
|
NA Days
Standard Deviation NA
No participants had a dose modification at this dose.
|
NA Days
Standard Deviation NA
No participants had a dose modification at this dose.
|
58 Days
Standard Deviation 39
|
58 Days
Standard Deviation 11
|
128 Days
Standard Deviation 148
|
32 Days
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition. A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.
Outcome measures
| Measure |
All Participants
n=3 Participants
Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m\^2, 0.9 mg/m\^2, 1.1 mg/m\^2, or 1.3 mg/m\^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level.
|
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
n=3 Participants
Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
n=10 Participants
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
|---|---|---|---|---|---|---|
|
Clinical AE Summary
Who died
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical AE Summary
Who discontinued due to drug-related SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Clinical AE Summary
With one or more AEs
|
3 Participants
|
3 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Clinical AE Summary
With no AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical AE Summary
With drug-related AEs
|
2 Participants
|
3 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Clinical AE Summary
With Serious AEs (SAEs)
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Clinical AE Summary
With drug-related SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Clinical AE Summary
Who discontinued due to AEs
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Clinical AE Summary
Who discontinued due to drug-related AEs
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Clinical AE Summary
Who discontinued due to SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to disease progression, toxicity, or death, assessed up to 29 monthsAn AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition. A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose. A lab (S)AE was any lab value considered clinically significant in the investigator's judgment.
Outcome measures
| Measure |
All Participants
n=3 Participants
Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m\^2, 0.9 mg/m\^2, 1.1 mg/m\^2, or 1.3 mg/m\^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level.
|
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
n=3 Participants
Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
n=10 Participants
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
n=6 Participants
Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
|---|---|---|---|---|---|---|
|
Laboratory AE Summary
With one or more laboratory AEs
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Laboratory AE Summary
With no laboratory AEs
|
2 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
|
Laboratory AE Summary
With drug-related laboratory AEs
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Laboratory AE Summary
With laboratory Serious AEs (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory AE Summary
With drug-related laboratory SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory AE Summary
Who died
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory AE Summary
Who discontinued due to laboratory AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory AE Summary
Who discontinued due to drug-related lab AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory AE Summary
Who discontinued due to laboratory SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Laboratory AE Summary
Who discontinued due to drug-related lab SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Vorinostat 200 mg + Bortezomib 0.7 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vorinostat 200 mg + Bortezomib 0.7 mg/m^2
n=3 participants at risk
Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
n=3 participants at risk
Vorinostat capsules given b.i.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
n=10 participants at risk
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
n=6 participants at risk
Vorinostat capsules given q.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
n=6 participants at risk
Vorinostat capsules given q.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
n=6 participants at risk
Vorinostat capsules given q.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Tremor
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
Other adverse events
| Measure |
Vorinostat 200 mg + Bortezomib 0.7 mg/m^2
n=3 participants at risk
Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
n=3 participants at risk
Vorinostat capsules given b.i.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
|
Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
n=10 participants at risk
Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
n=6 participants at risk
Vorinostat capsules given q.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
n=6 participants at risk
Vorinostat capsules given q.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
n=6 participants at risk
Vorinostat capsules given q.d. Treatment in 21 day cycles
(participants received vorinostat for 14 days followed by a 7 day break).
Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
|
|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Dry eye
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
|
Eye disorders
Eye irritation
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Eye oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
30.0%
3/10 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 4
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 5
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 4
|
16.7%
1/6 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
100.0%
3/3 • Number of events 6
|
50.0%
5/10 • Number of events 12
|
33.3%
2/6 • Number of events 3
|
83.3%
5/6 • Number of events 19
|
66.7%
4/6 • Number of events 7
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Eye pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
50.0%
3/6 • Number of events 15
|
33.3%
2/6 • Number of events 3
|
33.3%
2/6 • Number of events 4
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 3
|
16.7%
1/6 • Number of events 3
|
|
Eye disorders
Scintillating scotoma
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 3
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
66.7%
2/3 • Number of events 6
|
33.3%
1/3 • Number of events 2
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
2/6 • Number of events 3
|
66.7%
4/6 • Number of events 7
|
50.0%
3/6 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
33.3%
1/3 • Number of events 5
|
80.0%
8/10 • Number of events 13
|
66.7%
4/6 • Number of events 18
|
100.0%
6/6 • Number of events 36
|
100.0%
6/6 • Number of events 17
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 4
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2
|
100.0%
3/3 • Number of events 12
|
60.0%
6/10 • Number of events 13
|
83.3%
5/6 • Number of events 24
|
50.0%
3/6 • Number of events 19
|
100.0%
6/6 • Number of events 24
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
60.0%
6/10 • Number of events 7
|
50.0%
3/6 • Number of events 7
|
50.0%
3/6 • Number of events 4
|
83.3%
5/6 • Number of events 8
|
|
General disorders
Asthenia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
|
General disorders
Chest discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Chest pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Chills
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Early satiety
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Face oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2
|
100.0%
3/3 • Number of events 6
|
50.0%
5/10 • Number of events 12
|
100.0%
6/6 • Number of events 20
|
33.3%
2/6 • Number of events 11
|
83.3%
5/6 • Number of events 33
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Infusion site erythema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Infusion site pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Injection site reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Malaise
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Metaplasia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Oedema
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Oedema peripheral
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 5
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
50.0%
5/10 • Number of events 7
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Ulcer
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Ear infection
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Eye infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Localised infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3
|
0.00%
0/3
|
30.0%
3/10 • Number of events 3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
33.3%
2/6 • Number of events 6
|
33.3%
2/6 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
30.0%
3/10 • Number of events 4
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 3
|
0.00%
0/6
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
33.3%
2/6 • Number of events 5
|
0.00%
0/6
|
|
Investigations
Blood glucose increased
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Investigations
Heart rate increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 9
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 4
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
66.7%
4/6 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
66.7%
2/3 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
33.3%
2/6 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
|
0.00%
0/3
|
40.0%
4/10 • Number of events 4
|
33.3%
2/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
50.0%
3/6 • Number of events 3
|
0.00%
0/6
|
16.7%
1/6 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 2
|
16.7%
1/6 • Number of events 6
|
16.7%
1/6 • Number of events 7
|
33.3%
2/6 • Number of events 6
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 3
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 8
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3
|
33.3%
1/3 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
50.0%
3/6 • Number of events 6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
50.0%
5/10 • Number of events 8
|
33.3%
2/6 • Number of events 3
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Nervous system disorders
Tremor
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
|
Renal and urinary disorders
Bladder irritation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/3
|
30.0%
3/10 • Number of events 4
|
50.0%
3/6 • Number of events 4
|
33.3%
2/6 • Number of events 5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
|
0.00%
0/3
|
30.0%
3/10 • Number of events 3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3
|
0.00%
0/3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
0.00%
0/3
|
20.0%
2/10 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Vascular disorders
Flushing
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/10
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER