Trial Outcomes & Findings for An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma. (NCT NCT00555906)
NCT ID: NCT00555906
Last Updated: 2015-03-19
Results Overview
MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (\<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever \>=38.5degrees Celsius (C); Grade \>=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 corrected QT interval (QTc) prolongation (QTc \>500 millisecond \[msec\]) in asymptomatic participants even after repeat testing to exclude confounding factors and correction of reversible causes; Delay in the administration of Cycle 2 for more than 1 week of the planned date due to platelet count \<25,000/mcL and/or ANC \<500/mcL, or due to prolonged nonhematologic toxicities of Grade \>=3; Inability to deliver at least 80 percent (%) of the planned PD 0332991 or bortezomib doses during Cycle 1 due to toxicity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule B
Results posted on
2015-03-19
Participant Flow
Participant milestones
| Measure |
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
Palbociclib (PD 0332991) 100 milligram (mg) capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 milligram per square meter (mg/m\^2) intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|---|
|
Phase 1
STARTED
|
3
|
6
|
7
|
5
|
0
|
|
Phase 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
3
|
6
|
7
|
5
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
0
|
32
|
|
Phase 2
Treated
|
0
|
0
|
0
|
0
|
30
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
32
|
Reasons for withdrawal
| Measure |
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
Palbociclib (PD 0332991) 100 milligram (mg) capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 milligram per square meter (mg/m\^2) intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|---|
|
Phase 1
Objective Progression or Relapse
|
3
|
5
|
3
|
1
|
0
|
|
Phase 1
Global Deterioration of Health Status
|
0
|
1
|
1
|
1
|
0
|
|
Phase 1
Adverse Event
|
0
|
0
|
3
|
2
|
0
|
|
Phase 1
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
|
Phase 2
Adverse Event
|
0
|
0
|
0
|
0
|
4
|
|
Phase 2
Global Deterioration of Health Status
|
0
|
0
|
0
|
0
|
2
|
|
Phase 2
Objective Progression or Relapse
|
0
|
0
|
0
|
0
|
16
|
|
Phase 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
|
Phase 2
Other
|
0
|
0
|
0
|
0
|
6
|
|
Phase 2
Randomized but not Treated
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.
Baseline characteristics by cohort
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=9 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule B)
n=12 Participants
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase2:ScheduleB)
n=32 Participants
Included all participants who received palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to 44 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Age, Customized
45 to 64 years
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
19 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule BPopulation: DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.
MTD=highest dose level for which no more than 1 out of 6 participants experienced dose-limiting toxicity (DLT). DLT=any of the following treatment-related events: Absolute neutrophil count (ANC) less than (\<)1000/microliter (mcL) (Grade 3 neutropenia) associated with documented infection/fever \>=38.5degrees Celsius (C); Grade \>=3 nonhematologic treatment-related toxicity, except those that were not maximally treated or considered tolerable, Grade 3 corrected QT interval (QTc) prolongation (QTc \>500 millisecond \[msec\]) in asymptomatic participants even after repeat testing to exclude confounding factors and correction of reversible causes; Delay in the administration of Cycle 2 for more than 1 week of the planned date due to platelet count \<25,000/mcL and/or ANC \<500/mcL, or due to prolonged nonhematologic toxicities of Grade \>=3; Inability to deliver at least 80 percent (%) of the planned PD 0332991 or bortezomib doses during Cycle 1 due to toxicity.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=9 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
n=12 Participants
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of PD-0332991: Phase 1
|
NA milligram (mg)
For Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A), reported DLTs were \>1/6 (exceeding the MTD criteria), hence no MTD could be determined for Schedule A.
|
100 milligram (mg)
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 28 during Cycle 1 in schedule A, Day 1 up to Day 21 during Cycle 1 in schedule BPopulation: DLT analysis set included all enrolled participants who received at least one dose of study treatment and did not have a major deviation in the first cycle.
RP2D was determined based on the MTD, safety and tolerability profile of the study treatment.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=9 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
n=12 Participants
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Recommended Phase II Dose (RP2D) of PD-0332991: Phase 1
|
NA milligram (mg)
Both palbociclib 75 mg+bortezomib+dexamethasone and palbociclib 100 mg+bortezomib+dexamethasone had DLT \>1/6, hence no RP2D was selected from these 2 dosing groups.
|
100 milligram (mg)
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 (baseline) up to end of study (up to cycle 22 for schedule B)Population: Primary response analysis set (PRAS) included first consecutive (by first treatment day) participants in response analysis set (RAS=included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable.
OR: confirmed stringent complete response(sCR),complete response(CR),very good partial response(VGPR) or partial response(PR) as per International Myeloma Working Group Uniform Response Criteria (IMWGURC). sCR: normal serum free light chain (FLC) ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, \<5 percent (%) plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, \>= 90% reduction in serum M-protein, \<100 mg/24 hour (hr) urine M-protein. PR: \>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by \>=90% or to \<200 mg/24 hr, \>=50% decrease in difference between involved and uninvolved FLC levels if serum, urine M-protein were unmeasurable, \>= 50% reduction in plasma cells, provided baseline bone marrow plasma cell was \>=30% if serum, urine M-protein were unmeasurable and serum free light assay was unmeasureable.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=25 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Percentage of Participants With Objective Response (OR): Phase 2
|
20 percentage of participants
Interval 6.8 to 40.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening, C1D1(baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)Population: Results are not reported because data was present as individual participant listings but not summarized for analysis, as per change in planned analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (baseline), assessed on Day 1 of every cycle up to end of study (up to Cycle 22 for schedule A and schedule B)Population: RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.
Best overall response: best confirmed response on study after first study dose as per IMWGURC. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, \>=90% reduction in serum M-protein, \<100 mg/24 hr urine M-protein. PR: \>=50% reduction of serum M-protein, reduction in 24-hr urinary M-protein by \>=90% or to \<200mg/24 hr. Progressive disease (PD): \>=25% increase from lowest response level in serum M-component or urine M-component, \>=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder. Stable disease (SD): criteria for CR, VGPR, PR or PD not met.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=1 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
n=5 Participants
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
n=7 Participants
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
n=5 Participants
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Best Overall Response: Phase 1
Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Best Overall Response: Phase 1
Very Good Partial Response
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Best Overall Response: Phase 1
Stringent Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Best Overall Response: Phase 1
Partial Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Best Overall Response: Phase 1
Stable Disease
|
0 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Best Overall Response: Phase 1
Progressive Disease
|
1 participants
|
3 participants
|
3 participants
|
1 participants
|
|
Best Overall Response: Phase 1
Indeterminate
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclibPopulation: RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.
TTP was defined as the time from first dose of study medication to first documentation of objective tumor progression. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\] per IMWGURC). PD: \>=25% increase from lowest response level in serum M-component or urine M-component, \>=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=30 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Time to Tumor Progression (TTP): Phase 2
|
3.9 months
Interval 1.4 to 7.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclibPopulation: RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.
PFS was the time from start of study treatment to date progressive disease was documented or death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death"). PD: \>=25% increase from lowest response level in serum M-component or urine M-component, \>=10% bone marrow plasma cell percentage, definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=30 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS): Phase 2
|
3.9 months
Interval 1.4 to 7.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclibPopulation: PRAS was defined as the first consecutive (by first treatment day) participants in RAS (RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease) that were response-evaluable. DR was calculated for the subgroup of PRAS participants with objective response.
DR was defined as time from first documentation of objective tumor response (sCR, CR, VGPR or PR) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause since treatment started. sCR: normal FLC ratio, absence of clonal cells in bone marrow. CR: disappearance of any soft tissue plasmacytomas, \<5% plasma cells in bone marrow, negative immunofixation on serum, urine. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis, \>=90% reduction in serum M-protein, \<100 mg/24hr urine M-protein. PR:\>=50% reduction in serum M-protein, reduction in 24-hr urinary M-protein by \>=90% or to \<200 mg/24 hr. PD: \>=25% increase from lowest response level in serum M-component, urine M-component, \>=10% bone marrow plasma cell percentage, development of new bone lesions/soft tissue plasmacytomas/increase in size of existing bone lesions, development of hypercalcemia, attributed solely to plasma cell proliferative disorder.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=5 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Duration of Objective Response (DR): Phase 2
|
4.63 months
Interval 1.643 to
Upper limit of 95% could not be estimated since very few number of participants had response.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (baseline) up to end of study (up to Cycle 22 for schedule B), thereafter every 3 months until 1 year after the last dose of palbociclibPopulation: RAS included all enrolled participants who received study treatment, had an adequate baseline tumor assessment and measurable disease.
OS was defined as the time from first dose of study medication to first documentation of death due to any cause. OS was calculated as (the death date or last known alive date \[if death date unavailable\] minus the date of first dose of study medication plus 1) divided by 30.44.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=30 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Overall Survival (OS): Phase 2
|
21.1 months
Interval 11.8 to
Upper limit of confidence interval could not be estimated since majority of the participants were alive at the time of analysis.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclibPopulation: Safety analysis set (SAS) included all enrolled participants who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded according to the common terminology criteria for adverse events (CTCAE) criteria as 1=mild AE, 2=moderate AE, 3=severe AE, 4=life-threatening or disabling AE, 5=Death related to AE. The most severe grade was used in case of multiple occurrences of the same event.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=30 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) by Severity: Phase 2
Grade 3
|
9 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) by Severity: Phase 2
Grade 2
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) by Severity: Phase 2
Grade 4
|
18 participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) by Severity: Phase 2
Grade 5
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclibPopulation: SAS included all enrolled participants who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication until 28 days after the last dose of study medication that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study medication, which occurred during the trial. Treatment-related were adverse events (serious as well as non-serious adverse events) considered related to study medication by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=30 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Medication: Phase 2
All Causality
|
30 participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Medication: Phase 2
Treatment Related
|
27 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (baseline) up to 28 days after last dose of palbociclibPopulation: SAS included all enrolled participants who received at least 1 dose of study treatment.
Laboratory parameters included hematology (hemoglobin, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid); electrolytes (sodium, potassium, chloride, bicarbonate, calcium, magnesium and phosphate); urinalysis (protein and immunology \[C reactive protein\]), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=30 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities: Phase 2
|
30 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)Population: Patient Reported Outcomes (PRO) analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores for functional scales, global health status and symptom scales were calculated as an average of individual items, transformed to 0-100 scale; higher score=better level of functioning, health status or greater degree of symptoms. Score of the single items were transformed to 0-100 scale; higher score=greater degree of symptom/difficulty.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=27 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of treatment: Global health status (n=17)
|
49.02 units on a scale
Interval 34.7 to 63.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Physical Functioning (n=17)
|
56.08 units on a scale
Interval 45.0 to 67.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Role Functioning (n=17)
|
56.86 units on a scale
Interval 38.4 to 75.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Emotional Functioning (n=17)
|
62.26 units on a scale
Interval 49.1 to 75.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Cognitive Functioning (n=17)
|
62.75 units on a scale
Interval 48.7 to 76.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Social Functioning (n=17)
|
65.69 units on a scale
Interval 48.2 to 83.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Fatigue (n=17)
|
37.74 units on a scale
Interval 24.6 to 50.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Nausea and Vomiting (n=17)
|
16.67 units on a scale
Interval 4.5 to 28.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Pain (n=17)
|
43.14 units on a scale
Interval 26.0 to 60.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Dyspnea (n=17)
|
41.18 units on a scale
Interval 24.5 to 57.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Insomnia (n=17)
|
49.02 units on a scale
Interval 30.7 to 67.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Appetite Loss (n=17)
|
25.49 units on a scale
Interval 10.0 to 41.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Constipation (n=17)
|
43.14 units on a scale
Interval 27.4 to 58.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Diarrhea (n=17)
|
5.88 units on a scale
Interval -3.2 to 14.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
End of Treatment: Financial Problems (n=17)
|
45.10 units on a scale
Interval 27.0 to 63.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Emotional Functioning (n=6)
|
61.11 units on a scale
Interval 56.6 to 99.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Global Health Status (n=27)
|
60.80 units on a scale
Interval 50.7 to 70.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Physical Functioning (n=27)
|
64.20 units on a scale
Interval 55.6 to 72.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Role Functioning (n=27)
|
59.88 units on a scale
Interval 46.8 to 73.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Emotional Functioning (n=27)
|
70.37 units on a scale
Interval 59.8 to 80.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Cognitive Functioning (n=27)
|
72.22 units on a scale
Interval 62.0 to 82.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Social Functioning (n=27)
|
69.14 units on a scale
Interval 57.6 to 80.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Fatigue (n=27)
|
29.63 units on a scale
Interval 19.1 to 40.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Nausea and Vomiting (n=27)
|
6.79 units on a scale
Interval 2.2 to 11.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Pain (n=27)
|
35.80 units on a scale
Interval 22.0 to 49.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Dyspnea (n=27)
|
32.10 units on a scale
Interval 21.4 to 42.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Insomnia (n=27)
|
43.21 units on a scale
Interval 29.1 to 57.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Appetite Loss (n=27)
|
20.99 units on a scale
Interval 8.8 to 33.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Constipation (n=27)
|
27.16 units on a scale
Interval 12.5 to 41.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Diarrhea (n=27)
|
11.11 units on a scale
Interval 4.8 to 17.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D1: Financial Problems (n=26)
|
33.33 units on a scale
Interval 17.2 to 49.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Global Health Status (n=26)
|
60.58 units on a scale
Interval 51.4 to 69.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Physical Functioning (n=26)
|
67.18 units on a scale
Interval 58.2 to 76.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Role Functioning (n=26)
|
59.62 units on a scale
Interval 47.0 to 72.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Emotional Functioning (n=26)
|
72.76 units on a scale
Interval 61.5 to 84.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Cognitive Functioning (n=26)
|
69.87 units on a scale
Interval 56.8 to 82.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Social Functioning (n=26)
|
70.51 units on a scale
Interval 58.3 to 82.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Fatigue (n=26)
|
27.24 units on a scale
Interval 16.0 to 38.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Nausea and Vomiting (n=26)
|
12.82 units on a scale
Interval 4.9 to 20.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Pain (n=26)
|
42.31 units on a scale
Interval 29.6 to 55.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Dyspnea (n=26)
|
30.77 units on a scale
Interval 18.2 to 43.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Insomnia (n=26)
|
43.59 units on a scale
Interval 29.0 to 58.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Appetite Loss (n=26)
|
24.36 units on a scale
Interval 10.3 to 38.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Constipation (n=26)
|
34.62 units on a scale
Interval 19.2 to 50.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Diarrhea (n=26)
|
15.38 units on a scale
Interval 5.1 to 25.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D8: Financial Problems
|
28.20 units on a scale
Interval 15.2 to 41.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Global Health Status
|
55.33 units on a scale
Interval 45.2 to 65.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Physical Functioning (n=25)
|
62.93 units on a scale
Interval 54.1 to 71.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Role Functioning (n=25)
|
52.67 units on a scale
Interval 38.4 to 66.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Emotional Functioning (n=25)
|
67.00 units on a scale
Interval 55.2 to 78.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Cognitive Functioning (n=25)
|
68.00 units on a scale
Interval 56.8 to 79.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Social Functioning (n=25)
|
64.00 units on a scale
Interval 50.3 to 77.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Fatigue (n=25)
|
33.00 units on a scale
Interval 21.2 to 44.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Nausea and Vomiting (n=25)
|
20.67 units on a scale
Interval 10.5 to 30.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Pain (n=25)
|
45.33 units on a scale
Interval 32.7 to 58.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Dyspnea (n=25)
|
42.67 units on a scale
Interval 28.6 to 56.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Insomnia (n=25)
|
40.00 units on a scale
Interval 28.8 to 51.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Appetite Loss (n=25)
|
29.33 units on a scale
Interval 14.8 to 43.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Constipation (n=25)
|
32.00 units on a scale
Interval 16.9 to 47.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Diarrhea (n=25)
|
20.00 units on a scale
Interval 7.4 to 32.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C1D15: Financial Problems (n=25)
|
29.33 units on a scale
Interval 16.0 to 42.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Global Health Status (n=25)
|
52.33 units on a scale
Interval 42.7 to 62.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Physical Functioning (n=25)
|
63.73 units on a scale
Interval 55.1 to 72.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Role Functioning (n=25)
|
60.67 units on a scale
Interval 50.2 to 71.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Emotional Functioning (n=25)
|
65.67 units on a scale
Interval 53.9 to 77.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Cognitive Functioning (n=25)
|
72.00 units on a scale
Interval 61.7 to 82.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Social Functioning (n=25)
|
64.67 units on a scale
Interval 52.5 to 76.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Fatigue (n=25)
|
34.33 units on a scale
Interval 22.5 to 46.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Nausea and Vomiting (n=25)
|
12.67 units on a scale
Interval 7.0 to 18.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Pain (n=25)
|
43.33 units on a scale
Interval 31.6 to 55.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Dyspnea (n=25)
|
33.33 units on a scale
Interval 22.8 to 43.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Insomnia (n=25)
|
40.00 units on a scale
Interval 28.1 to 51.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Appetite Loss (n=25)
|
22.67 units on a scale
Interval 9.7 to 35.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Constipation (n=25)
|
21.33 units on a scale
Interval 7.1 to 35.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Diarrhea (n=25)
|
6.67 units on a scale
Interval 1.0 to 12.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C2D1: Financial Problems (n=25)
|
29.33 units on a scale
Interval 14.3 to 44.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Global Health Status (n=25)
|
56.82 units on a scale
Interval 48.1 to 65.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Physical Functioning (n=25)
|
68.18 units on a scale
Interval 59.2 to 77.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Role Functioning (n=22)
|
62.88 units on a scale
Interval 48.5 to 77.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Emotional Functioning (n=22)
|
68.56 units on a scale
Interval 56.5 to 80.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Cognitive Functioning (n=22)
|
71.97 units on a scale
Interval 59.8 to 84.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Social Functioning (n=22)
|
70.45 units on a scale
Interval 57.6 to 83.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Fatigue (n=22)
|
31.44 units on a scale
Interval 19.4 to 43.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Nausea and Vomiting (n=22)
|
14.39 units on a scale
Interval 5.5 to 23.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Pain (n=22)
|
30.30 units on a scale
Interval 16.7 to 43.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Dyspnea (n=22)
|
36.36 units on a scale
Interval 22.0 to 50.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Insomnia (n=22)
|
36.36 units on a scale
Interval 25.3 to 47.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Appetite Loss (n=22)
|
22.73 units on a scale
Interval 12.1 to 33.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Constipation (n=22)
|
36.36 units on a scale
Interval 22.0 to 50.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Diarrhea (n=22)
|
6.06 units on a scale
Interval -1.3 to 13.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C3D1: Financial Problems (n=22)
|
34.85 units on a scale
Interval 19.4 to 50.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Global Health Status (n=18)
|
59.72 units on a scale
Interval 49.6 to 69.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Physical Functioning (n=18)
|
63.15 units on a scale
Interval 51.0 to 75.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Role Functioning (n=18)
|
60.19 units on a scale
Interval 44.6 to 75.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Emotional Functioning (n=18)
|
67.13 units on a scale
Interval 53.8 to 80.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Cognitive Functioning (n=18)
|
71.30 units on a scale
Interval 57.7 to 84.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Social Functioning (n=18)
|
64.81 units on a scale
Interval 48.5 to 81.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Fatigue (n=18)
|
32.87 units on a scale
Interval 19.5 to 46.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Nausea and Vomiting (n=18)
|
9.26 units on a scale
Interval 2.2 to 16.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Pain (n=18)
|
30.56 units on a scale
Interval 16.8 to 44.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Dyspnea (n=18)
|
37.04 units on a scale
Interval 24.5 to 49.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Insomnia (n=18)
|
35.19 units on a scale
Interval 19.6 to 50.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Appetite Loss (n=18)
|
20.37 units on a scale
Interval 5.2 to 35.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Constipation (n=18)
|
33.33 units on a scale
Interval 17.3 to 49.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Diarrhea (n=18)
|
5.56 units on a scale
Interval -3.0 to 14.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C4D1: Financial Problems (n=18)
|
33.33 units on a scale
Interval 17.3 to 49.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1:Global Health Status (n=17)
|
52.45 units on a scale
Interval 42.2 to 62.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Physical Functioning (n=17)
|
58.04 units on a scale
Interval 47.1 to 69.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Role Functioning (n=17)
|
56.86 units on a scale
Interval 41.4 to 72.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Emotional Functioning (n=17)
|
65.20 units on a scale
Interval 49.5 to 80.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Cognitive Functioning (n=17)
|
67.65 units on a scale
Interval 52.1 to 83.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Social Functioning (n=17)
|
59.80 units on a scale
Interval 42.9 to 76.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Fatigue (n=17)
|
34.80 units on a scale
Interval 19.1 to 50.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Nausea and Vomiting (n=17)
|
11.76 units on a scale
Interval 4.5 to 19.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Pain (n=17)
|
31.37 units on a scale
Interval 16.3 to 46.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Dyspnea (n=17)
|
45.10 units on a scale
Interval 28.0 to 62.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Insomnia (n=17)
|
27.45 units on a scale
Interval 13.6 to 41.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Appetite Loss (n=17)
|
17.65 units on a scale
Interval 3.9 to 31.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Constipation (n=17)
|
35.29 units on a scale
Interval 18.7 to 51.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Diarrhea (n=17)
|
9.80 units on a scale
Interval -3.4 to 23.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C5D1: Financial Problems (n=17)
|
27.45 units on a scale
Interval 9.0 to 45.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Global Health Status (n=15)
|
61.11 units on a scale
Interval 50.8 to 71.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Physical Functioning (n=15)
|
65.78 units on a scale
Interval 55.6 to 75.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Role Functioning (n=15)
|
61.11 units on a scale
Interval 45.3 to 77.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Emotional Functioning (n=15)
|
73.89 units on a scale
Interval 59.1 to 88.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Cognitive Functioning (n=15)
|
72.22 units on a scale
Interval 56.0 to 88.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Social Functioning (n=15)
|
71.11 units on a scale
Interval 55.3 to 86.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Fatigue (n=15)
|
26.11 units on a scale
Interval 11.3 to 40.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Nausea and Vomiting (n=15)
|
7.78 units on a scale
Interval 0.1 to 15.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Pain (n=15)
|
27.78 units on a scale
Interval 14.9 to 40.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Dyspnea (n=15)
|
31.11 units on a scale
Interval 18.1 to 44.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Insomnia (n=15)
|
31.11 units on a scale
Interval 14.8 to 47.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Appetite Loss (n=15)
|
11.11 units on a scale
Interval -4.0 to 26.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Constipation (n=15)
|
28.89 units on a scale
Interval 10.6 to 47.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Diarrhea (n=15)
|
4.44 units on a scale
Interval -2.1 to 10.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C6D1: Financial Problems (n=15)
|
26.67 units on a scale
Interval 9.3 to 44.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Global Health Status (n=11)
|
53.79 units on a scale
Interval 42.2 to 65.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Physical Functioning (n=11)
|
56.36 units on a scale
Interval 42.6 to 70.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Role Functioning (n=11)
|
51.52 units on a scale
Interval 27.8 to 75.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Emotional Functioning (n=11)
|
66.67 units on a scale
Interval 45.3 to 88.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Cognitive Functioning (n=11)
|
74.24 units on a scale
Interval 53.4 to 95.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Social Functioning (n=11)
|
68.18 units on a scale
Interval 46.1 to 90.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Fatigue (n=11)
|
33.33 units on a scale
Interval 11.9 to 54.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Nausea and Vomiting (n=11)
|
12.12 units on a scale
Interval 2.0 to 22.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Pain (n=11)
|
37.88 units on a scale
Interval 13.8 to 61.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Dyspnea (n=11)
|
20.00 units on a scale
Interval 3.3 to 36.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Insomnia (n=11)
|
30.30 units on a scale
Interval 9.2 to 51.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Appetite Loss (n=11)
|
6.06 units on a scale
Interval -7.4 to 19.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Constipation (n=11)
|
27.27 units on a scale
Interval 7.7 to 46.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Diarrhea (n=11)
|
12.12 units on a scale
Interval -3.0 to 27.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C7D1: Financial Problems (n=11)
|
27.27 units on a scale
Interval 5.3 to 49.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Global Health Status (n=10)
|
62.50 units on a scale
Interval 48.7 to 76.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Physical Functioning (n=10)
|
56.00 units on a scale
Interval 39.0 to 73.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Role Functioning (n=10)
|
58.33 units on a scale
Interval 34.3 to 82.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Emotional Functioning (n=10)
|
78.33 units on a scale
Interval 65.4 to 91.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Cognitive Functioning (n=10)
|
78.33 units on a scale
Interval 60.5 to 96.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Social Functioning (n=10)
|
73.33 units on a scale
Interval 57.2 to 89.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Fatigue (n=10)
|
21.67 units on a scale
Interval 8.7 to 34.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Nausea and Vomiting (n=10)
|
5.00 units on a scale
Interval -0.8 to 10.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Pain (n=10)
|
31.67 units on a scale
Interval 12.6 to 50.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Dyspnea (n=10)
|
30.00 units on a scale
Interval 6.3 to 53.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Insomnia (n=10)
|
36.67 units on a scale
Interval 10.4 to 62.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Appetite Loss (n=10)
|
10.00 units on a scale
Interval -1.5 to 21.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Constipation (n=10)
|
20.00 units on a scale
Interval -0.1 to 40.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Diarrhea (n=10)
|
0.00 units on a scale
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C8D1: Financial Problems (n=10)
|
40.00 units on a scale
Interval 15.4 to 64.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Global Health Status (n=9)
|
56.48 units on a scale
Interval 41.5 to 71.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Physical Functioning (n=9)
|
57.78 units on a scale
Interval 39.5 to 76.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Role Functioning (n=9)
|
68.52 units on a scale
Interval 43.3 to 93.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Emotional Functioning (n=9)
|
75.00 units on a scale
Interval 62.2 to 87.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Cognitive Functioning (n=9)
|
72.22 units on a scale
Interval 49.1 to 95.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Social Functioning (n=9)
|
74.07 units on a scale
Interval 57.0 to 91.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Fatigue (n=9)
|
25.00 units on a scale
Interval 12.2 to 37.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Nausea and Vomiting (n=9)
|
5.56 units on a scale
Interval -0.9 to 12.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Pain (n=9)
|
25.92 units on a scale
Interval 14.6 to 37.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Dyspnea (n=9)
|
33.33 units on a scale
Interval 11.1 to 55.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Insomnia (n=9)
|
40.74 units on a scale
Interval 19.4 to 62.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Appetite Loss (n=9)
|
11.11 units on a scale
Interval -7.0 to 29.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Constipation (n=9)
|
18.52 units on a scale
Interval -0.1 to 37.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Diarrhea (n=9)
|
7.41 units on a scale
Interval -9.7 to 24.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C9D1: Financial Problems (n=9)
|
40.74 units on a scale
Interval 12.7 to 68.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Global Health Status (n=6)
|
52.78 units on a scale
Interval 26.4 to 79.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Physical Functioning (n=6)
|
52.22 units on a scale
Interval 38.6 to 65.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Role Functioning (n=6)
|
50.00 units on a scale
Interval 18.7 to 81.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Emotional Functioning (n=6)
|
70.83 units on a scale
Interval 42.2 to 99.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Cognitive Functioning (n=6)
|
75.00 units on a scale
Interval 48.5 to 101.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Social Functioning (n=6)
|
83.33 units on a scale
Interval 61.2 to 105.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Fatigue (n=6)
|
29.17 units on a scale
Interval 0.6 to 57.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Nausea and Vomiting (n=6)
|
2.78 units on a scale
Interval -4.4 to 9.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Pain (n=6)
|
33.33 units on a scale
Interval 14.2 to 52.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Dyspnea (n=6)
|
33.33 units on a scale
Interval -10.9 to 77.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Insomnia (n=6)
|
44.45 units on a scale
Interval 15.9 to 73.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Appetite Loss (n=6)
|
16.67 units on a scale
Interval -12.6 to 45.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Constipation (n=6)
|
16.67 units on a scale
Interval -12.6 to 45.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Diarrhea (n=6)
|
0.00 units on a scale
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C10D1: Financial Problems (n=6)
|
38.89 units on a scale
Interval -12.6 to 90.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Global Health Status (n=5)
|
61.67 units on a scale
Interval 39.0 to 84.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Physical Functioning (n=5)
|
54.67 units on a scale
Interval 39.9 to 69.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Role Functioning (n=5)
|
53.33 units on a scale
Interval 26.3 to 80.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Emotional Functioning (n=5)
|
65.00 units on a scale
Interval 29.6 to 100.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Cognitive Functioning (n=5)
|
73.33 units on a scale
Interval 30.4 to 116.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Social Functioning (n=5)
|
66.66 units on a scale
Interval 37.4 to 95.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Fatigue (n=5)
|
35.00 units on a scale
Interval -0.4 to 70.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Nausea and Vomiting (n=5)
|
6.67 units on a scale
Interval -11.8 to 25.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Pain (n=5)
|
30.00 units on a scale
Interval 7.3 to 52.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Dyspnea (n=5)
|
20.00 units on a scale
Interval -17.0 to 57.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Insomnia (n=5)
|
40.00 units on a scale
Interval 21.5 to 58.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Appetite Loss (n=5)
|
13.33 units on a scale
Interval -9.3 to 36.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Constipation (n=5)
|
13.33 units on a scale
Interval -23.7 to 50.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Diarrhea (n=5)
|
6.67 units on a scale
Interval -11.8 to 25.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C11D1: Financial Problems (n=5)
|
26.67 units on a scale
Interval -18.7 to 72.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Global Health Status (n=15)
|
45.00 units on a scale
Interval 9.5 to 80.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Physical Functioning (n=15)
|
52.00 units on a scale
Interval 36.1 to 67.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Role Functioning (n=15)
|
43.33 units on a scale
Interval 8.7 to 78.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Emotional Functioning (n=15)
|
63.33 units on a scale
Interval 20.9 to 105.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Cognitive Functioning (n=15)
|
70.00 units on a scale
Interval 43.0 to 97.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Social Functioning (n=15)
|
50.00 units on a scale
Interval 24.7 to 75.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Fatigue (n=15)
|
36.67 units on a scale
Interval -5.7 to 79.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Nausea and Vomiting (n=15)
|
6.67 units on a scale
Interval -11.8 to 25.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Pain (n=15)
|
43.33 units on a scale
Interval 24.8 to 61.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Dyspnea (n=15)
|
40.00 units on a scale
Interval -14.0 to 94.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Insomnia (n=15)
|
33.33 units on a scale
Interval 4.1 to 62.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Appetite Loss (n=15)
|
26.67 units on a scale
Interval -8.0 to 61.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Constipation (n=15)
|
6.67 units on a scale
Interval -11.8 to 25.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Diarrhea (n=15)
|
13.33 units on a scale
Interval -9.3 to 36.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C12D1: Financial Problems (n=15)
|
46.67 units on a scale
Interval -0.5 to 93.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Global Health Status (n=6)
|
54.17 units on a scale
Interval 27.2 to 81.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Physical Functioning (n=6)
|
53.34 units on a scale
Interval 38.0 to 68.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Role Functioning (n=6)
|
55.56 units on a scale
Interval 19.4 to 91.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Emotional Functioning (n=6)
|
69.44 units on a scale
Interval 32.5 to 106.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Cognitive Functioning (n=6)
|
69.44 units on a scale
Interval 39.3 to 99.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Social Functioning (n=6)
|
61.11 units on a scale
Interval 34.8 to 87.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Fatigue (n=6)
|
30.56 units on a scale
Interval -6.4 to 67.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Nausea and Vomiting (n=6)
|
5.56 units on a scale
Interval -8.7 to 19.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Pain (n=6)
|
27.78 units on a scale
Interval 9.7 to 45.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Dyspnea (n=6)
|
22.22 units on a scale
Interval -6.3 to 50.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Insomnia (n=6)
|
27.78 units on a scale
Interval -6.6 to 62.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Appetite Loss (n=6)
|
16.67 units on a scale
Interval -2.5 to 35.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Constipation (n=6)
|
16.67 units on a scale
Interval -12.6 to 45.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Diarrhea (n=6)
|
22.22 units on a scale
Interval -20.1 to 64.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C13D1: Financial Problems (n=6)
|
38.89 units on a scale
Interval -2.0 to 79.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Global Health Status (n=6)
|
61.11 units on a scale
Interval 43.9 to 78.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Physical Functioning (n=6)
|
54.45 units on a scale
Interval 40.9 to 68.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Role Functioning (n=6)
|
50.00 units on a scale
Interval 27.9 to 72.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Emotional Functioning (n=6)
|
73.61 units on a scale
Interval 45.7 to 101.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Cognitive Functioning (n=6)
|
83.33 units on a scale
Interval 61.2 to 105.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Social Functioning (n=6)
|
69.45 units on a scale
Interval 41.4 to 97.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Fatigue (n=6)
|
26.39 units on a scale
Interval -1.5 to 54.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Nausea and Vomiting (n=6)
|
2.78 units on a scale
Interval -4.4 to 9.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Pain (n=6)
|
33.33 units on a scale
Interval 14.2 to 52.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Dyspnea (n=6)
|
22.22 units on a scale
Interval 4.2 to 40.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Insomnia (n=6)
|
22.22 units on a scale
Interval -6.3 to 50.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Appetite Loss (n=6)
|
0.00 units on a scale
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Constipation (n=6)
|
16.67 units on a scale
Interval -12.6 to 45.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Diarrhea (n=6)
|
5.56 units on a scale
Interval -8.7 to 19.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C14D1: Financial Problems (n=6)
|
33.33 units on a scale
Interval -10.9 to 77.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Global Health Status (n=6)
|
66.67 units on a scale
Interval 52.0 to 81.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Physical Functioning (n=6)
|
52.23 units on a scale
Interval 40.2 to 64.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Role Functioning (n=6)
|
61.11 units on a scale
Interval 34.8 to 87.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Cognitive Functioning (n=6)
|
72.22 units on a scale
Interval 39.7 to 104.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Social Functioning (n=6)
|
66.67 units on a scale
Interval 35.4 to 98.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Fatigue (n=6)
|
22.22 units on a scale
Interval 1.0 to 43.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Nausea and Vomiting (n=6)
|
2.78 units on a scale
Interval -4.4 to 9.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Pain (n=6)
|
27.78 units on a scale
Interval 3.9 to 51.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Dyspnea (n=6)
|
27.78 units on a scale
Interval 1.4 to 54.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Insomnia (n=6)
|
22.22 units on a scale
Interval 4.2 to 40.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Appetite Loss (n=6)
|
5.56 units on a scale
Interval -8.7 to 19.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Constipation (n=6)
|
16.67 units on a scale
Interval -12.6 to 45.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Diarrhea (n=6)
|
5.56 units on a scale
Interval -8.7 to 19.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C15D1: Financial Problems (n=6)
|
44.45 units on a scale
Interval 2.1 to 86.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Global Health Status (n=6)
|
52.78 units on a scale
Interval 28.9 to 76.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Physical Functioning (n=6)
|
55.56 units on a scale
Interval 46.0 to 65.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Role Functioning (n=6)
|
50.00 units on a scale
Interval 30.8 to 69.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Emotional Functioning (n=6)
|
76.39 units on a scale
Interval 47.4 to 105.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Cognitive Functioning (n=6)
|
77.78 units on a scale
Interval 56.6 to 99.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Social Functioning (n=6)
|
69.44 units on a scale
Interval 37.3 to 101.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Fatigue (n=6)
|
23.61 units on a scale
Interval -5.4 to 52.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Nausea and Vomiting (n=6)
|
0.00 units on a scale
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Pain (n=6)
|
33.33 units on a scale
Interval 8.6 to 58.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Dyspnea (n=6)
|
27.78 units on a scale
Interval 1.4 to 54.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Insomnia (n=6)
|
27.78 units on a scale
Interval 1.4 to 54.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Appetite Loss (n=6)
|
5.56 units on a scale
Interval -8.7 to 19.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Constipation (n=6)
|
11.11 units on a scale
Interval -17.5 to 39.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Diarrhea (n=6)
|
22.22 units on a scale
Interval -6.3 to 50.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C16D1: Financial Problems (n=6)
|
44.45 units on a scale
Interval 2.1 to 86.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Global Health Status (n=6)
|
55.56 units on a scale
Interval 35.1 to 76.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Physical Functioning (n=6)
|
51.11 units on a scale
Interval 32.5 to 69.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Role Functioning (n=6)
|
58.34 units on a scale
Interval 43.7 to 73.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Emotional Functioning (n=6)
|
73.61 units on a scale
Interval 44.1 to 103.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Cognitive Functioning (n=6)
|
72.22 units on a scale
Interval 43.7 to 100.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Social Functioning (n=6)
|
72.22 units on a scale
Interval 45.9 to 98.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Fatigue (n=6)
|
26.39 units on a scale
Interval -3.1 to 55.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Nausea and Vomiting (n=6)
|
2.78 units on a scale
Interval -4.4 to 9.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Pain (n=6)
|
30.56 units on a scale
Interval 2.5 to 58.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Dyspnea (n=6)
|
22.22 units on a scale
Interval -6.3 to 50.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Insomnia (n=6)
|
50.00 units on a scale
Interval 7.2 to 92.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Appetite Loss (n=6)
|
5.56 units on a scale
Interval -8.7 to 19.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Constipation (n=6)
|
22.22 units on a scale
Interval -13.9 to 58.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Diarrhea (n=6)
|
5.56 units on a scale
Interval -8.7 to 19.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C17D1: Financial Problems (n=6)
|
44.45 units on a scale
Interval 2.1 to 86.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Global Health Status (n=6)
|
61.11 units on a scale
Interval 43.9 to 78.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Physical Functioning (n=6)
|
48.89 units on a scale
Interval 37.5 to 60.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Role Functioning (n=6)
|
50.00 units on a scale
Interval 25.3 to 74.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Emotional Functioning (n=6)
|
70.83 units on a scale
Interval 34.7 to 107.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Cognitive Functioning (n=6)
|
61.11 units on a scale
Interval 18.7 to 103.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Social Functioning (n=6)
|
63.89 units on a scale
Interval 31.8 to 96.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Fatigue (n=6)
|
29.17 units on a scale
Interval -7.0 to 65.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Nausea and Vomiting (n=6)
|
8.33 units on a scale
Interval -13.1 to 29.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Pain (n=6)
|
61.11 units on a scale
Interval 25.0 to 97.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Dyspnea (n=6)
|
33.33 units on a scale
Interval 11.2 to 55.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Insomnia (n=6)
|
33.33 units on a scale
Interval 2.0 to 64.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Appetite Loss (n=6)
|
22.22 units on a scale
Interval -6.3 to 50.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Constipation (n=6)
|
22.22 units on a scale
Interval -13.9 to 58.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Diarrhea (n=6)
|
5.56 units on a scale
Interval -8.7 to 19.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C18D1: Financial Problems (n=6)
|
44.44 units on a scale
Interval -3.4 to 92.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Global Health Status (n=4)
|
45.83 units on a scale
Interval 20.4 to 71.2
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Physical Functioning (n=4)
|
45.00 units on a scale
Interval 23.1 to 66.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Role Functioning (n=4)
|
37.50 units on a scale
Interval -7.8 to 82.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Emotional Functioning (n=4)
|
66.67 units on a scale
Interval 9.4 to 124.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Cognitive Functioning (n=4)
|
45.83 units on a scale
Interval -39.1 to 130.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Social Functioning (n=4)
|
50.00 units on a scale
Interval 12.5 to 87.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Fatigue (n=4)
|
33.33 units on a scale
Interval -24.0 to 90.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Nausea and Vomiting (n=4)
|
12.50 units on a scale
Interval -12.9 to 37.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Pain (n=4)
|
58.33 units on a scale
Interval 24.1 to 92.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Dyspnea (n=4)
|
25.00 units on a scale
Interval -1.5 to 51.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Insomnia (n=4)
|
41.67 units on a scale
Interval -25.1 to 108.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Appetite Loss (n=4)
|
25.00 units on a scale
Interval -1.5 to 51.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Constipation (n=4)
|
50.00 units on a scale
Interval -18.5 to 118.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Diarrhea (n=4)
|
0.00 units on a scale
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C19D1: Financial Problems (n=4)
|
41.67 units on a scale
Interval -25.1 to 108.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Global Health Status (n=2)
|
37.50 units on a scale
Interval -15.5 to 90.5
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Physical Functioning (n=2)
|
46.67 units on a scale
Interval -38.0 to 131.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Role Functioning (n=2)
|
33.33 units on a scale
Interval 33.3 to 33.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Emotional Functioning (n=2)
|
33.33 units on a scale
Interval -284.0 to 351.0
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Cognitive Functioning (n=2)
|
16.67 units on a scale
Interval 16.6 to 16.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Social Functioning (n=2)
|
41.67 units on a scale
Interval -64.2 to 147.6
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Fatigue (n=2)
|
66.67 units on a scale
Interval -251.0 to 384.3
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Nausea and Vomiting (n=2)
|
16.67 units on a scale
Interval -195.0 to 228.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Pain (n=2)
|
66.67 units on a scale
Interval 66.6 to 66.7
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Dyspnea (n=2)
|
33.34 units on a scale
Interval -390.0 to 456.9
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Insomnia (n=2)
|
50.00 units on a scale
Interval -162.0 to 261.8
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Appetite Loss (n=2)
|
33.33 units on a scale
Interval 33.3 to 33.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Constipation (n=2)
|
16.67 units on a scale
Interval -195.0 to 228.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Diarrhea (n=2)
|
16.67 units on a scale
Interval -195.0 to 228.4
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C20D1: Financial Problems (n=2)
|
83.34 units on a scale
Interval -128.0 to 295.1
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Global Health Status (n=1)
|
41.67 units on a scale
95% Confidence Interval (CI) was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Physical Functioning (n=1)
|
53.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Role Functioning (n=1)
|
50.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Emotional Functioning (n=1)
|
66.67 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Cognitive Functioning (n=1)
|
0.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Social Functioning (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Fatigue (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Nausea and Vomiting (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Pain (n=1)
|
66.67 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Dyspnea (n=1)
|
0.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Insomnia (n=1)
|
66.67 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Appetite Loss (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Constipation (n=1)
|
0.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Diarrhea (n=1)
|
0.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C21D1: Financial Problems (n=1)
|
100.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Global Health Status (n=1)
|
16.67 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Physical Functioning (n=1)
|
53.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Role Functioning (n=1)
|
50.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Emotional Functioning (n=1)
|
83.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Cognitive Functioning (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Social Functioning (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Fatigue (n=1)
|
16.67 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Nausea and Vomiting (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Pain (n=1)
|
83.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Dyspnea (n=1)
|
0.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Insomnia (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Appetite Loss (n=1)
|
0.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Constipation (n=1)
|
0.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Diarrhea (n=1)
|
0.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30): Phase 2
C22D1: Financial Problems (n=1)
|
100.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)Population: PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment. Here 'n' signifies those participants who were evaluable at spefied time points for each arm, respectively.
The QLQ-MY20 consisted of 20 items addressing 4 domains of health-related quality of life (HRQoL) important to participants with multiple myeloma: future perspective (2 items), pain/disease symptoms (6 items), social support /body image (2 items), and treatment side-effects (10 items). All items used 4 point scale (1 'Not at all' to 4 'Very much'). Scores for HRQoL domains were calculated as an average of the individual items, transformed to 0 to 100 range. Higher scores on symptom scales (disease symptoms and side effects of treatment) indicated a higher level of symptoms/problems. Higher scores on functional scales (future perspective and body image) indicated a higher level of QoL/functioning.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=27 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C16D1: Body Image (n=6)
|
22.22 units on a scale
Interval -13.9 to 58.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D1: Disease Symptoms (n=27)
|
35.68 units on a scale
Interval 25.5 to 45.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D1: Side Effects of Treatment (n=27)
|
25.61 units on a scale
Interval 17.7 to 33.5
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D1: Future Perspective (n=27)
|
46.50 units on a scale
Interval 36.4 to 56.6
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D1: Body Image (n=27)
|
24.69 units on a scale
Interval 11.2 to 38.2
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D8: Disease Symptoms (n=25)
|
35.51 units on a scale
Interval 25.3 to 45.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D8: Side Effects of Treatment (n=25)
|
23.90 units on a scale
Interval 16.1 to 31.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D8: Future Perspective (n=25)
|
44.44 units on a scale
Interval 32.9 to 56.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D8: Body Image (n=25)
|
13.33 units on a scale
Interval 3.6 to 23.1
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D15: Disease Symptoms (n=25)
|
32.31 units on a scale
Interval 22.7 to 41.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D15: Side Effects of Treatment (n=25)
|
26.89 units on a scale
Interval 19.8 to 33.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D15: Future Perspective (n=25)
|
48.89 units on a scale
Interval 37.0 to 60.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C1D15: Body Image (n=25)
|
28.00 units on a scale
Interval 14.4 to 41.6
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C2D1: Disease Symptoms (n=25)
|
29.82 units on a scale
Interval 21.4 to 38.3
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C2D1: Side Effects of Treatment (n=25)
|
24.73 units on a scale
Interval 18.5 to 31.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C2D1: Future Perspective (n=25)
|
46.22 units on a scale
Interval 35.0 to 57.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C2D1: Body Image (n=25)
|
17.33 units on a scale
Interval 7.5 to 27.2
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C3D1: Disease Symptoms (n=21)
|
25.13 units on a scale
Interval 16.2 to 34.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C3D1: Side Effects of Treatment (n=21)
|
25.01 units on a scale
Interval 18.1 to 31.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C3D1: Future Perspective (n=21)
|
44.44 units on a scale
Interval 31.7 to 57.1
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C3D1: Body Image (n=21)
|
20.63 units on a scale
Interval 10.5 to 30.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C4D1: Disease Symptoms (n=18)
|
28.71 units on a scale
Interval 17.8 to 39.6
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C4D1: Side Effects of Treatment (n=18)
|
26.64 units on a scale
Interval 18.0 to 35.3
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C4D1: Future Perspective (n=18)
|
44.45 units on a scale
Interval 28.7 to 60.2
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C4D1: Body Image (n=18)
|
25.93 units on a scale
Interval 8.4 to 43.5
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C5D1: Disease Symptoms (n=17)
|
27.78 units on a scale
Interval 15.2 to 40.3
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C5D1: Side Effects of Treatment (n=17)
|
27.52 units on a scale
Interval 19.1 to 36.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C5D1: Future Perspective (n=17)
|
45.75 units on a scale
Interval 29.1 to 62.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C5D1: Body Image (n=17)
|
25.49 units on a scale
Interval 11.2 to 39.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C6D1: Disease Symptoms (n=15)
|
24.08 units on a scale
Interval 14.0 to 34.1
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C6D1: Side Effects of Treatment (n=15)
|
25.04 units on a scale
Interval 15.2 to 34.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C6D1: Future Perspective (n=15)
|
40.74 units on a scale
Interval 22.2 to 59.3
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C6D1: Body Image (n=15)
|
20.00 units on a scale
Interval 1.8 to 38.2
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C7D1: Disease Symptoms (n=11)
|
25.96 units on a scale
Interval 11.8 to 40.2
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C7D1: Side Effects of Treatment (n=11)
|
26.77 units on a scale
Interval 11.5 to 42.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C7D1: Future Perspective (n=11)
|
44.44 units on a scale
Interval 23.1 to 65.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C7D1: Body Image (n=11)
|
30.30 units on a scale
Interval 9.2 to 51.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C8D1: Disease Symptoms (n=10)
|
18.56 units on a scale
Interval 9.3 to 27.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C8D1: Side Effects of Treatment (n=10)
|
26.41 units on a scale
Interval 9.8 to 43.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C8D1: Future Perspective (n=10)
|
35.56 units on a scale
Interval 15.8 to 55.3
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C8D1: Body Image (n=10)
|
30.00 units on a scale
Interval 9.1 to 50.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C9D1: Disease Symptoms (n=9)
|
19.14 units on a scale
Interval 8.7 to 29.6
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C9D1: Side Effects of Treatment (n=9)
|
19.75 units on a scale
Interval 10.8 to 28.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C9D1: Future Perspective (n=9)
|
39.51 units on a scale
Interval 18.5 to 60.5
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C9D1: Body Image (n=9)
|
25.93 units on a scale
Interval 4.6 to 47.3
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C10D1: Disease Symptoms (n=6)
|
25.93 units on a scale
Interval 17.1 to 34.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C10D1: Side Effects of Treatment (n=6)
|
18.83 units on a scale
Interval 5.9 to 31.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C10D1: Future Perspective (n=6)
|
33.33 units on a scale
Interval -4.3 to 70.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C10D1: Body Image (n=6)
|
16.67 units on a scale
Interval -12.6 to 45.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C11D1: Disease Symptoms (n=6)
|
18.52 units on a scale
Interval 7.7 to 29.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C11D1: Side Effects of Treatment (n=6)
|
18.52 units on a scale
Interval 7.3 to 29.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C11D1: Future Perspective (n=6)
|
38.89 units on a scale
Interval -4.6 to 82.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C11D1: Body Image (n=6)
|
22.22 units on a scale
Interval -6.3 to 50.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C12D1: Disease Symptoms (n=5)
|
28.89 units on a scale
Interval 18.7 to 39.1
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C12D1: Side Effects of Treatment (n=5)
|
24.30 units on a scale
Interval 8.1 to 40.5
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C12D1: Future Perspective (n=5)
|
53.33 units on a scale
Interval -2.2 to 108.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C12D1: Body Image (n=5)
|
40.00 units on a scale
Interval -14.0 to 94.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C13D1: Disease Symptoms (n=6)
|
25.00 units on a scale
Interval 14.1 to 35.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C13D1: Side Effects of Treatment (n=6)
|
18.70 units on a scale
Interval 5.4 to 32.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C13D1: Future Perspective (n=6)
|
37.04 units on a scale
Interval -5.8 to 79.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C13D1: Body Image (n=6)
|
33.33 units on a scale
Interval 2.0 to 64.6
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C14D1: Disease Symptoms (n=6)
|
19.45 units on a scale
Interval 11.4 to 27.5
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C14D1: Side Effects of Treatment (n=6)
|
18.64 units on a scale
Interval 5.3 to 32.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C14D1: Future Perspective (n=6)
|
35.19 units on a scale
Interval -9.3 to 79.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C14D1: Body Image (n=6)
|
16.67 units on a scale
Interval -12.6 to 45.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C15D1: Disease Symptoms (n=6)
|
23.15 units on a scale
Interval 6.9 to 39.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C15D1: Side Effects of Treatment (n=6)
|
18.09 units on a scale
Interval 8.2 to 28.0
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C15D1: Future Perspective (n=6)
|
38.89 units on a scale
Interval -4.6 to 82.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C15D1: Body Image (n=6)
|
16.67 units on a scale
Interval -12.6 to 45.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C16D1: Disease Symptoms (n=6)
|
27.78 units on a scale
Interval 9.3 to 46.2
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C16D1: Side Effects of Treatment (n=6)
|
16.91 units on a scale
Interval 5.0 to 28.9
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C16D1: Future Perspective (n=6)
|
37.04 units on a scale
Interval -5.8 to 79.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C17D1: Disease Symptoms (n=6)
|
24.07 units on a scale
Interval 11.0 to 37.2
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C17D1: Side Effects of Treatment (n=6)
|
19.26 units on a scale
Interval 5.0 to 33.6
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C17D1: Future Perspective (n=6)
|
38.89 units on a scale
Interval -2.7 to 80.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C17D1: Body Image (n=6)
|
22.22 units on a scale
Interval -6.3 to 50.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C18D1: Disease Symptoms (n=6)
|
41.85 units on a scale
Interval 25.9 to 57.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C18D1: Side Effects of Treatment (n=6)
|
18.52 units on a scale
Interval 4.8 to 32.2
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C18D1: Future Perspective (n=6)
|
38.89 units on a scale
Interval -2.7 to 80.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C18D1: Body Image (n=6)
|
33.33 units on a scale
Interval 2.0 to 64.6
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C19D1: Disease Symptoms (n=4)
|
43.06 units on a scale
Interval 18.7 to 67.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C19D1: Side Effects of Treatment (n=4)
|
25.74 units on a scale
Interval 4.6 to 46.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C19D1: Future Perspective (n=4)
|
38.89 units on a scale
Interval -29.6 to 107.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C19D1: Body Image (n=4)
|
41.67 units on a scale
Interval -25.1 to 108.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C20D1: Disease Symptoms (n=2)
|
44.45 units on a scale
Interval -96.8 to 185.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C20D1: Side Effects of Treatment (n=2)
|
35.19 units on a scale
Interval 11.6 to 58.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C20D1: Future Perspective (n=2)
|
66.67 units on a scale
Interval -357.0 to 490.2
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C20D1: Body Image (n=2)
|
50.00 units on a scale
Interval -162.0 to 261.8
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C21D1: Disease Symptoms (n=1)
|
77.78 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C21D1: Side Effects of Treatment (n=1)
|
36.67 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C21D1: Future Perspective (n=1)
|
44.44 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C21D1: Body Image (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C22D1: Disease Symptoms (n=1)
|
61.11 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C22D1: Side Effects of Treatment (n=1)
|
33.33 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C22D1: Future Perspective (n=1)
|
44.44 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
C22D1: Body Image (n=1)
|
66.67 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
End of Treatment: Disease Symptoms (n=17)
|
37.58 units on a scale
Interval 23.5 to 51.7
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
End of Treatment: Side Effects of Treatment (n=17)
|
29.51 units on a scale
Interval 21.5 to 37.6
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
End of Treatment: Future Perspective (n=17)
|
46.41 units on a scale
Interval 34.4 to 58.4
|
—
|
—
|
—
|
|
Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY20): Phase 2
End of Treatment: Body Image (n=17)
|
29.41 units on a scale
Interval 13.5 to 45.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)Population: The PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment.'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively.
m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 "No pain" to 10 "Pain as bad as you can imagine". The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference.
Outcome measures
| Measure |
Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
n=26 Participants
Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)
Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C1D1: Pain Severity (n=26)
|
2.32 units on a scale
Interval 1.4 to 3.2
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C1D8: Pain Severity (n=25)
|
2.62 units on a scale
Interval 1.7 to 3.6
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C1D15: Pain Severity (n=24)
|
2.44 units on a scale
Interval 1.5 to 3.4
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C2D1: Pain Severity (n=24)
|
2.30 units on a scale
Interval 1.5 to 3.2
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C3D1: Pain Severity (n=21)
|
2.12 units on a scale
Interval 1.2 to 3.1
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C4D1: Pain Severity (n=17)
|
2.02 units on a scale
Interval 0.9 to 3.1
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C5D1: Pain Severity (n=16)
|
2.22 units on a scale
Interval 1.0 to 3.4
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C6D1: Pain Severity (n=14)
|
1.66 units on a scale
Interval 0.7 to 2.6
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C7D1: Pain Severity (n=10)
|
1.98 units on a scale
Interval 0.5 to 3.5
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C8D1: Pain Severity (n=9)
|
2.47 units on a scale
Interval 0.6 to 4.4
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C9D1: Pain Severity (n=9)
|
1.81 units on a scale
Interval 0.5 to 3.1
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C10D1: Pain Severity (n=6)
|
1.08 units on a scale
Interval -0.1 to 2.3
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C11D1: Pain Severity (n=5)
|
1.45 units on a scale
Interval 0.0 to 2.9
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C12D1: Pain Severity (n=5)
|
1.67 units on a scale
Interval 0.4 to 2.9
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C13D1: Pain Severity (n=6)
|
0.93 units on a scale
Interval 0.1 to 1.7
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C14D1: Pain Severity (n=6)
|
1.42 units on a scale
Interval 0.1 to 2.7
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C15D1: Pain Severity (n=6)
|
1.04 units on a scale
Interval 0.0 to 2.1
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C16D1: Pain Severity (n=6)
|
1.46 units on a scale
Interval 0.0 to 2.9
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C17D1: Pain Severity (n=6)
|
1.67 units on a scale
Interval -0.3 to 3.6
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C18D1: Pain Severity (n=6)
|
2.88 units on a scale
Interval 1.1 to 4.7
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C19D1: Pain Severity (n=4)
|
3.69 units on a scale
Interval 1.3 to 6.1
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C20D1: Pain Severity (n=2)
|
3.50 units on a scale
Interval 0.3 to 6.7
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C21D1: Pain Severity (n=1)
|
4.00 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C22D1: Pain Severity (n=1)
|
4.50 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
End of Treatment: Pain Severity (n=16)
|
3.30 units on a scale
Interval 1.9 to 4.6
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C1D1: Pain Interference (n=25)
|
2.53 units on a scale
Interval 1.4 to 3.6
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C1D8: Pain Interference (n=25)
|
2.58 units on a scale
Interval 1.4 to 3.7
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C1D15: Pain Interference (n=23)
|
3.06 units on a scale
Interval 1.9 to 4.3
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C2D1: Pain Interference (n=23)
|
2.64 units on a scale
Interval 1.5 to 3.7
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C3D1: Pain Interference (n=21)
|
2.34 units on a scale
Interval 1.1 to 3.5
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C4D1: Pain Interference (n=17)
|
2.54 units on a scale
Interval 1.2 to 3.9
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C5D1: Pain Interference (n=16)
|
2.74 units on a scale
Interval 1.3 to 4.2
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C6D1: Pain Interference (n=14)
|
2.26 units on a scale
Interval 0.8 to 3.7
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C7D1: Pain Interference (n=10)
|
2.94 units on a scale
Interval 0.6 to 5.3
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C8D1: Pain Interference (n=9)
|
2.60 units on a scale
Interval 0.6 to 4.6
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C9D1: Pain Interference (n=9)
|
2.13 units on a scale
Interval 0.0 to 4.3
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C10D1: Pain Interference (n=6)
|
2.07 units on a scale
Interval -0.1 to 4.2
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C11D1: Pain Interference (n=5)
|
2.40 units on a scale
Interval 1.1 to 3.7
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C12D1: Pain Interference (n=5)
|
2.91 units on a scale
Interval 1.0 to 4.8
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C13D1: Pain Interference (n=6)
|
1.90 units on a scale
Interval 0.3 to 3.5
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C14D1: Pain Interference (n=6)
|
0.98 units on a scale
Interval -0.1 to 2.1
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C15D1: Pain Interference (n=6)
|
1.31 units on a scale
Interval 0.2 to 2.4
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C16D1: Pain Interference (n=6)
|
1.83 units on a scale
Interval 0.4 to 3.3
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C17D1: Pain Interference (n=6)
|
1.50 units on a scale
Interval 0.4 to 2.6
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C18D1: Pain Interference (n=6)
|
2.86 units on a scale
Interval 0.9 to 4.9
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C19D1: Pain Interference (n=4)
|
4.07 units on a scale
Interval 2.1 to 6.0
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C20D1: Pain Interference (n=2)
|
5.07 units on a scale
Interval -14.0 to 24.1
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C21D1: Pain Interference (n=1)
|
2.57 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
C22D1: Pain Interference (n=1)
|
6.71 units on a scale
95% CI was not estimable since only 1 participant was evaluable.
|
—
|
—
|
—
|
|
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
End of Treatment: Pain Interference (n=16)
|
3.46 units on a scale
Interval 1.9 to 5.0
|
—
|
—
|
—
|
Adverse Events
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)
Serious events: 10 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
n=3 participants at risk
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
n=6 participants at risk
Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
n=7 participants at risk
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
n=5 participants at risk
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)
n=30 participants at risk
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Disease progression
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
n=3 participants at risk
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)
n=6 participants at risk
Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
n=7 participants at risk
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)
n=5 participants at risk
Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)
n=30 participants at risk
Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
56.7%
17/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Hyperviscosity syndrome
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
5/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
100.0%
6/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
80.0%
4/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
36.7%
11/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
3/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
83.3%
5/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
71.4%
5/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
80.0%
4/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
76.7%
23/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Chalazion
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid ptosis
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
30.0%
9/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
12/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
36.7%
11/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.3%
4/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
6/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
70.0%
21/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Gait disturbance
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
60.0%
3/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.7%
8/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
3/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.7%
8/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.3%
4/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bicarbonate increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood bilirubin decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood chloride increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
6/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood sodium increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Body height decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.3%
4/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
5/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
6/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
30.0%
9/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
5/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.3%
4/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.7%
8/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
6/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.7%
8/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
66.7%
2/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypogeusia
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
30.0%
9/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Stress
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
23.3%
7/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
40.0%
2/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
26.7%
8/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
33.3%
1/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Social circumstances
Walking aid user
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.3%
4/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Haemoglobinaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye disorder
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye irritation
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye swelling
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.3%
4/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingival inflammation
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Palatal oedema
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Catheter site pruritus
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Injection site reaction
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Irritability
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Spinal pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.3%
4/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Infection
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Cardiac murmur
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Clostridium test positive
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Granulocyte count decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Troponin increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
pH urine increased
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Listless
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
10.0%
3/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
13.3%
4/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.7%
2/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Pallor
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
1/30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER