Trial Outcomes & Findings for A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (NCT NCT01566721)
NCT ID: NCT01566721
Last Updated: 2021-04-27
Results Overview
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2577 participants
Primary outcome timeframe
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Results posted on
2021-04-27
Participant Flow
Of the 2984 participants screened, a total of 2577 participants were enrolled into the trial, and 2573 participants received at least one dose of study treatment. 4 Participants were not included in the Safety Follow-Up (SFU) ITT due to the lack of Principal Investigator signatures.
Participant milestones
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by Single-Use Injection Device (SID)
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|
|
Treatment Period
STARTED
|
1867
|
710
|
|
Treatment Period
COMPLETED
|
1670
|
652
|
|
Treatment Period
NOT COMPLETED
|
197
|
58
|
|
Safety Follow-up
STARTED
|
1865
|
708
|
|
Safety Follow-up
COMPLETED
|
1318
|
501
|
|
Safety Follow-up
NOT COMPLETED
|
547
|
207
|
Reasons for withdrawal
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by Single-Use Injection Device (SID)
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|
|
Treatment Period
Withdrawal by Subject
|
35
|
9
|
|
Treatment Period
Disease Progression/Recurrence
|
37
|
13
|
|
Treatment Period
Investigator/Sponsor Decision
|
6
|
3
|
|
Treatment Period
Other
|
13
|
2
|
|
Treatment Period
Lack of Compliance
|
5
|
1
|
|
Treatment Period
Adverse Event
|
100
|
30
|
|
Treatment Period
Pregnancy
|
1
|
0
|
|
Safety Follow-up
Physician Decision
|
6
|
4
|
|
Safety Follow-up
Lost to Follow-up
|
101
|
48
|
|
Safety Follow-up
Withdrawal by Subject
|
155
|
49
|
|
Safety Follow-up
Death
|
28
|
4
|
|
Safety Follow-up
Non-compliance
|
7
|
3
|
|
Safety Follow-up
Protocol Violation
|
7
|
0
|
|
Safety Follow-up
Site closure
|
2
|
3
|
|
Safety Follow-up
Erroneous reporting or late reporting
|
2
|
0
|
|
Safety Follow-up
Missing
|
7
|
2
|
|
Safety Follow-up
Disease progression /disease recurrence
|
223
|
90
|
|
Safety Follow-up
Sponsor decision
|
1
|
0
|
|
Safety Follow-up
Adverse Event
|
8
|
4
|
Baseline Characteristics
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1867 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=710 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Total
n=2577 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 11.32 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 11.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1863 Participants
n=5 Participants
|
710 Participants
n=7 Participants
|
2573 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)Population: Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1864 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=709 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period
|
88.6 percentage of participants
|
89.0 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)Population: Safety Population
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1864 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=709 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period
|
24.0 percentage of participants
Interval 22.1 to 26.0
|
21.0 percentage of participants
Interval 18.1 to 24.2
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)Population: Safety Population
Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1864 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=709 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Percentage of Participants With Treatment Interruption Due to an AE
|
9.8 percentage of participants
|
10.4 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)Population: Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.
Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=550 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=1864 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
n=709 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Number of Herceptin Cycles Received
|
16.0 cycles
Interval 1.0 to 17.0
|
18.0 cycles
Interval 1.0 to 19.0
|
18.0 cycles
Interval 1.0 to 18.0
|
PRIMARY outcome
Timeframe: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)Population: Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.
Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=550 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=1864 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
n=709 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
1 Cycle Received
|
2.7 percentage of participants
|
1.0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
2 Cycles Received
|
1.3 percentage of participants
|
0.5 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
3 Cycles Received
|
1.1 percentage of participants
|
0.5 percentage of participants
|
0.1 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
4 Cycles Received
|
1.6 percentage of participants
|
1.2 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
5 Cycles Received
|
1.3 percentage of participants
|
0.8 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
6 Cycles Received
|
1.6 percentage of participants
|
0.5 percentage of participants
|
0.1 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
7 Cycles Received
|
2.2 percentage of participants
|
0.7 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
8 Cycles Received
|
2.2 percentage of participants
|
0.9 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
9 Cycles Received
|
1.8 percentage of participants
|
0.2 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
10 Cycles Received
|
1.5 percentage of participants
|
0.3 percentage of participants
|
0.1 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
11 Cycles Received
|
3.5 percentage of participants
|
0.4 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
12 Cycles Received
|
2.5 percentage of participants
|
0.9 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
13 Cycles Received
|
4.9 percentage of participants
|
0.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
14 Cycles Received
|
6.9 percentage of participants
|
0.5 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
15 Cycles Received
|
10.7 percentage of participants
|
0.5 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
16 Cycles Received
|
21.6 percentage of participants
|
0.6 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
17 Cycles Received
|
32.5 percentage of participants
|
1.0 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
18 Cycles Received
|
0 percentage of participants
|
89.2 percentage of participants
|
91.8 percentage of participants
|
|
Percentage of Participants by Total Number of Herceptin Cycles Received
19 Cycles Received
|
0 percentage of participants
|
0.2 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)Population: Safety Population
Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1864 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=709 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Percentage of Participants Who Received Concomitant Cancer Therapy
Chemotherapy
|
58.2 percentage of participants
|
63.9 percentage of participants
|
—
|
|
Percentage of Participants Who Received Concomitant Cancer Therapy
Radiotherapy
|
51.3 percentage of participants
|
48.5 percentage of participants
|
—
|
|
Percentage of Participants Who Received Concomitant Cancer Therapy
Hormone Therapy
|
53.5 percentage of participants
|
50.4 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)Population: Safety Population
Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1864 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=709 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Percentage of Participants Who Received Concomitant Non-Cancer Therapy
|
89.1 percentage of participants
|
89.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)Population: ITT Population
The percentage of participants who died from any cause was reported.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1867 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=710 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Percentage of Participants Who Died by Data Cutoff of 10 March 2015
|
1.5 percentage of participants
|
0.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)Population: ITT Population
The percentage of participants who died from any cause was reported during the safety follow-up period.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1865 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=708 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Percentage of Participants Who Died During the Safety Follow-up Period
|
6.8 Percentage of Participants
|
7.3 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline to time of event (up to approximately 8 years)Population: ITT Population who completed Safety Follow-up
DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause. Time from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1865 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=708 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Disease-Free Survival Rate
0.5 Year
|
0.990 Kaplan-Meier survival probability
Interval 0.984 to 0.993
|
0.987 Kaplan-Meier survival probability
Interval 0.976 to 0.993
|
—
|
|
Disease-Free Survival Rate
1 Year
|
0.975 Kaplan-Meier survival probability
Interval 0.967 to 0.981
|
0.976 Kaplan-Meier survival probability
Interval 0.961 to 0.985
|
—
|
|
Disease-Free Survival Rate
1.5 Year
|
0.960 Kaplan-Meier survival probability
Interval 0.95 to 0.968
|
0.957 Kaplan-Meier survival probability
Interval 0.939 to 0.97
|
—
|
|
Disease-Free Survival Rate
2 Years
|
0.934 Kaplan-Meier survival probability
Interval 0.921 to 0.944
|
0.939 Kaplan-Meier survival probability
Interval 0.918 to 0.955
|
—
|
|
Disease-Free Survival Rate
3 Years
|
0.904 Kaplan-Meier survival probability
Interval 0.889 to 0.917
|
0.896 Kaplan-Meier survival probability
Interval 0.87 to 0.916
|
—
|
|
Disease-Free Survival Rate
4 Years
|
0.881 Kaplan-Meier survival probability
Interval 0.865 to 0.896
|
0.874 Kaplan-Meier survival probability
Interval 0.847 to 0.897
|
—
|
|
Disease-Free Survival Rate
5 Years
|
0.868 Kaplan-Meier survival probability
Interval 0.851 to 0.883
|
0.863 Kaplan-Meier survival probability
Interval 0.835 to 0.887
|
—
|
|
Disease-Free Survival Rate
6 Years
|
0.851 Kaplan-Meier survival probability
Interval 0.833 to 0.867
|
0.853 Kaplan-Meier survival probability
Interval 0.824 to 0.878
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Time of Event (Up to Approximately 6 Years)Population: ITT population: All randomized participants received at least one dose of drug and completed the follow up period
Overall survival was defined as the time from randomization to death from any cause. Time from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1865 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=708 Participants
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Overall Survival Rate
0.5 Year
|
0.999 Kaplan-Meier survival probability
Interval 0.996 to 1.0
|
0.996 Kaplan-Meier survival probability
Interval 0.987 to 0.999
|
—
|
|
Overall Survival Rate
1 Year
|
0.998 Kaplan-Meier survival probability
Interval 0.994 to 0.999
|
0.994 Kaplan-Meier survival probability
Interval 0.985 to 0.998
|
—
|
|
Overall Survival Rate
1.5 Year
|
0.993 Kaplan-Meier survival probability
Interval 0.988 to 0.996
|
0.990 Kaplan-Meier survival probability
Interval 0.979 to 0.995
|
—
|
|
Overall Survival Rate
2 Years
|
0.985 Kaplan-Meier survival probability
Interval 0.979 to 0.99
|
0.985 Kaplan-Meier survival probability
Interval 0.973 to 0.992
|
—
|
|
Overall Survival Rate
3 Years
|
0.968 Kaplan-Meier survival probability
Interval 0.958 to 0.975
|
0.960 Kaplan-Meier survival probability
Interval 0.942 to 0.972
|
—
|
|
Overall Survival Rate
4 Years
|
0.947 Kaplan-Meier survival probability
Interval 0.935 to 0.956
|
0.950 Kaplan-Meier survival probability
Interval 0.931 to 0.965
|
—
|
|
Overall Survival Rate
5 Years
|
0.937 Kaplan-Meier survival probability
Interval 0.925 to 0.948
|
0.929 Kaplan-Meier survival probability
Interval 0.907 to 0.947
|
—
|
|
Overall Survival Rate
6 Years
|
0.927 Kaplan-Meier survival probability
Interval 0.913 to 0.938
|
0.921 Kaplan-Meier survival probability
Interval 0.897 to 0.939
|
—
|
SECONDARY outcome
Timeframe: Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)Population: Safety Population. Only participants who performed self-administration were included. The number of participants who responded to the questionnaire item at each assessment (n) is shown in the table.
The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from "Strongly Disagree" to "Strongly Agree". Questionnaire items were as follows: "I felt comfortable injecting the study drug by myself" (Comfortable), "The SID was convenient and easy to use" (Easy to Use), "I am confident giving myself an injection in the thigh with the SID" (Confident), "Taking all things into account I find self-administration using the SID satisfactory" (Satisfactory), "If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire.
Outcome measures
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=550 Participants
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort B: SC Herceptin by SID
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Comfortable, Agree (n=514)
|
41.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Comfortable, Strongly Disagree (n=514)
|
4.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Comfortable, Disagree (n=514)
|
2.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Comfortable, Unsure (n=514)
|
7.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Comfortable, Strongly Agree (n=514)
|
43.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Comfortable, Response Missing (n=514)
|
0.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Easy to Use, Strongly Disagree (n=514)
|
3.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Easy to Use, Disagree (n=514)
|
0.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Easy to Use, Unsure (n=514)
|
1.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Easy to Use, Agree (n=514)
|
37.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Easy to Use, Strongly Agree (n=514)
|
56.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Easy to Use, Response Missing (n=514)
|
0.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Confident, Strongly Disagree (n=514)
|
3.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Confident, Disagree (n=514)
|
0.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Confident, Unsure (n=514)
|
7.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Confident, Agree (n=514)
|
42.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Confident, Strongly Agree (n=514)
|
45.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Confident, Response Missing (n=514)
|
0.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Satisfactory, Strongly Disagree (n=514)
|
3.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Satisfactory, Disagree (n=514)
|
0.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Satisfactory, Unsure (n=514)
|
2.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Satisfactory, Agree (n=514)
|
38.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Satisfactory, Strongly Agree (n=514)
|
53.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Satisfactory, Response Missing (n=514)
|
0.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Continue, Strongly Disagree (n=514)
|
3.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Continue, Disagree (n=514)
|
1.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Continue, Unsure (n=514)
|
5.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Continue, Agree (n=514)
|
33.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Continue, Strongly Agree (n=514)
|
55.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
Cycle 4: Continue, Response Missing (n=514)
|
0.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Comfortable, Strongly Disagree (n=415)
|
3.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Comfortable, Disagree (n=415)
|
3.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Comfortable, Unsure (n=415)
|
5.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Comfortable, Agree (n=415)
|
35.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Comfortable, Strongly Agree (n=415)
|
51.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Comfortable, Response Missing (n=415)
|
0.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Easy to Use, Strongly Disagree (n=415)
|
3.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Easy to Use, Disagree (n=415)
|
1.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Easy to Use, Unsure (n=415)
|
1.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Easy to Use, Agree (n=415)
|
34.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Easy to Use, Strongly Agree (n=415)
|
58.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Easy to Use, Response Missing (n=415)
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Confident, Strongly Disagree (n=415)
|
4.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Confident, Disagree (n=415)
|
1.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Confident, Unsure (n=415)
|
4.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Confident, Agree (n=415)
|
33.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Confident, Strongly Agree (n=415)
|
56.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Confident, Response Missing (n=415)
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Satisfactory, Strongly Disagree (n=415)
|
4.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Satisfactory, Disagree (n=415)
|
1.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Satisfactory, Unsure (n=415)
|
2.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Satisfactory, Agree (n=415)
|
30.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Satisfactory, Strongly Agree (n=415)
|
61.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Satisfactory, Response Missing (n=415)
|
0.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Continue, Strongly Disagree (n=415)
|
4.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Continue, Disagree (n=415)
|
1.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Continue, Unsure (n=415)
|
2.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Continue, Agree (n=415)
|
28.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Continue, Strongly Agree (n=415)
|
63.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants by Item Response to SID Satisfaction Questionnaire
LSFU: Continue, Response Missing (n=415)
|
0 percentage of participants
|
—
|
—
|
Adverse Events
Cohort A: SC Herceptin by Needle/Syringe
Serious events: 242 serious events
Other events: 1499 other events
Deaths: 0 deaths
Cohort B: SC Herceptin by SID
Serious events: 84 serious events
Other events: 576 other events
Deaths: 0 deaths
Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up
Serious events: 202 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B: SC Herceptin by SID Safety Follow-up
Serious events: 53 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1864 participants at risk
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=709 participants at risk
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up
n=1862 participants at risk
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID Safety Follow-up
n=707 participants at risk
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|---|
|
Infections and infestations
Neutropenic sepsis
|
0.48%
9/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Device related infection
|
0.32%
6/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Pneumonia
|
0.27%
5/1864 • Number of events 5 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.43%
8/1862 • Number of events 8 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/707 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Urinary tract infection
|
0.16%
3/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Mastitis
|
0.16%
3/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.21%
4/1862 • Number of events 4 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Cellulitis
|
0.21%
4/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.21%
4/1862 • Number of events 4 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Gastroenteritis
|
0.16%
3/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.21%
4/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Appendicitis
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Breast abscess
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Erysipelas
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Infectious colitis
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Pyelonephritis acute
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Viral infection
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Constipation
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Abscess of external auditory meatus
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Appendiceal abscess
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Bartholin's abscess
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Bronchopneumonia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Clostridium difficile infection
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Dengue fever
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Diverticulitis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Febrile infection
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Herpes zoster
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Intestinal sepsis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Lobar pneumonia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Localised infection
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Lung infection
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Meningoencephalitis bacterial
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Periorbital cellulitis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Postoperative wound infection
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Pyelonephritis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Respiratory tract infection
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Soft tissue infection
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Tracheobronchitis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Vaginal infection
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
39/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
2.0%
14/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.48%
9/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.85%
6/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.16%
3/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Thymus enlargement
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.43%
8/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.56%
4/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Nausea
|
0.27%
5/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.16%
3/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Vomiting
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Colitis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Subileus
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Pyrexia
|
0.59%
11/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.99%
7/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Product Issues
Device breakage
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
General physical health deterioration
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Asthenia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Chest discomfort
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Chest pain
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Death
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.32%
6/1862 • Number of events 6 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Device defective
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Fatigue
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Influenza like illness
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Mucosal inflammation
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Non- cardiac chest pain
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Oedema peripheral
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.54%
10/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.32%
6/1862 • Number of events 6 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Angina unstable
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Coronary artery disease
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Pericarditis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.16%
3/1862 • Number of events 3 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Atrial thrombosis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Myocarditis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Palpitations
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Traumatic arthropathy
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Wound
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Borderline serous tumour of ovary
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.81%
15/1862 • Number of events 15 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Headache
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Syncope
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 3 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Aphasia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/707 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Presyncope
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.21%
4/1862 • Number of events 4 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Hypertension
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Hypertensive crisis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Aortic aneurysm
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Phlebitis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Venous thrombosis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Venous thrombosis limb
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Investigations
Ejection fraction decreased
|
0.16%
3/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Investigations
White blood cell count decreased
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Investigations
Blood urea increased
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Investigations
Neutrophil count decreased
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.11%
2/1864 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.16%
3/1862 • Number of events 3 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.05%
1/1864 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Metabolism and nutrition disorders
Gout
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Psychiatric disorders
Anxiety
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Psychiatric disorders
Depression
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Psychiatric disorders
Panic attack
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Psychiatric disorders
Psychotic disorder
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Renal failure
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Urinary retention
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.16%
3/1862 • Number of events 3 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/707 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Immune system disorders
Drug hypersensitivity
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
2/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.05%
1/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Endocrine disorders
Thyroiditis Subacute
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Hepatobiliary disorders
Cholangitis Acute
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Hepatobiliary disorders
Acute Hepatic Failure
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Renal and urinary disorders
Urinary Bladder Polyp
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Lichen Sclerosus
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Breast Necrosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Fibrocystic Breast Disease
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Reproductive system and breast disorders
Breast Calcifications
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Disorder
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Thromboangiitis Obliterans
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Varicose Vein
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Sarcoidosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Dementia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Relapsing-Remitting Multiple Sclerosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Amyotrophic Lateral Sclerosis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Recurrent
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Gastric Cancer
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic Lymphoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Lobular Breast Carcinoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Adenocarcinoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondroma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Sarcoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Neoplasm
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Synovial Sarcoma Metastatic
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.16%
3/1862 • Number of events 3 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.28%
2/707 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Foreign Body Aspiration
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.16%
3/1862 • Number of events 3 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.16%
3/1862 • Number of events 3 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.32%
6/1862 • Number of events 6 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Cardiac Hypertrophy
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Sudden Death
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Infection
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.11%
2/1862 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Biliary Tract Infection
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Dengue Haemorrhagic Fever
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Diabetic Gangrene
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Enterobacter Sepsis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Kidney Infection
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Post Procedural Cellulitis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Pulmonary Sepsis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Pneumonia Influenzal
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval Cancer
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Epithelial Cancer Metastatic
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Eye disorders
Keratitis
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic Gestation
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.05%
1/1862 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 1 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
0.00%
0/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.14%
1/707 • Number of events 2 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
Other adverse events
| Measure |
Cohort A: SC Herceptin by Needle/Syringe
n=1864 participants at risk
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID
n=709 participants at risk
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up
n=1862 participants at risk
Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
|
Cohort B: SC Herceptin by SID Safety Follow-up
n=707 participants at risk
Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
20.4%
381/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
18.6%
132/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Asthenia
|
11.9%
221/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
12.0%
85/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Pyrexia
|
9.9%
185/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
7.8%
55/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Oedema peripheral
|
8.6%
160/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
6.3%
45/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Injection site erythema
|
6.9%
128/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
7.3%
52/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Mucosal inflammation
|
5.6%
105/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
7.5%
53/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Injection site pain
|
6.3%
117/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.2%
37/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Injection site reaction
|
5.4%
101/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.1%
36/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
General disorders
Pain
|
3.4%
63/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.1%
36/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.4%
362/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
18.8%
133/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.9%
260/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
11.8%
84/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.4%
194/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
6.9%
49/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
114/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.9%
42/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.8%
89/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.1%
36/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.8%
70/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.6%
40/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.4%
380/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
18.3%
130/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Nausea
|
14.7%
274/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
14.4%
102/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Constipation
|
8.2%
153/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
8.7%
62/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
129/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.4%
38/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
116/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.9%
42/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
87/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.1%
36/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.7%
69/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
6.2%
44/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Headache
|
12.2%
228/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
10.3%
73/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.5%
140/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
7.9%
56/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Paraesthesia
|
6.0%
112/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
9.9%
70/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Dizziness
|
6.0%
111/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
4.5%
32/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
94/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
3.0%
21/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.5%
177/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
10.4%
74/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.4%
156/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
10.4%
74/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
163/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
6.9%
49/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
115/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
4.9%
35/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
190/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
7.9%
56/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
115/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
6.6%
47/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.8%
109/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
4.2%
30/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
146/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
8.2%
58/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
113/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
3.0%
21/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
94/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
4.5%
32/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Hot flush
|
8.8%
164/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
10.2%
72/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Vascular disorders
Hypertension
|
7.6%
142/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
4.9%
35/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
130/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
6.1%
43/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.4%
101/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.1%
36/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
8.6%
161/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
9.6%
68/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Psychiatric disorders
Insomnia
|
5.8%
108/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
7.1%
50/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
|
Investigations
Ejection fraction decreased
|
4.3%
80/1864 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
5.1%
36/709 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/1862 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
0.00%
0/707 • Treatment Period: From Day 1 up to 19 cycles (approximately 1 year) 15 March 2015 Data Cutoff Safety Follow-up Period (SFU): From Day 1 to safety follow-up period (up to approximately 8 years)
Safety Population. During the Safety Follow-up Period, no non-Serious Adverse Events occurred at the 5% frequency threshold. In the Safety Follow-up period, 4 participants were not included in the final analyses due to the lack of Principal Investigator signatures in the participant specific casebooks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER