Trial Outcomes & Findings for Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib (NCT NCT01593254)
NCT ID: NCT01593254
Last Updated: 2023-06-22
Results Overview
Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals. P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (\<=4 weeks vs \>4 weeks).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
262 participants
Primary outcome timeframe
At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib.
Results posted on
2023-06-22
Participant Flow
260 participants treated
Participant milestones
| Measure |
Arm 1: Imatinib (≥400 mg)
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Arm 2: Dasatinib (100 mg)
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
174
|
|
Overall Study
Crossed Over to Dasatinib
|
46
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
86
|
174
|
Reasons for withdrawal
| Measure |
Arm 1: Imatinib (≥400 mg)
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Arm 2: Dasatinib (100 mg)
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
|---|---|---|
|
Overall Study
Disease progression
|
2
|
7
|
|
Overall Study
Study drug toxicity
|
6
|
20
|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
AE unrelated to study drug
|
0
|
1
|
|
Overall Study
participant request to discontinue study treatment
|
1
|
3
|
|
Overall Study
participant withdrew consent
|
0
|
9
|
|
Overall Study
lost to follow up
|
1
|
6
|
|
Overall Study
maximum clinical benefit
|
1
|
2
|
|
Overall Study
Poor/non compliance
|
1
|
1
|
|
Overall Study
Pregnancy
|
0
|
3
|
|
Overall Study
participant no longer meets study criteria
|
1
|
1
|
|
Overall Study
Admin reason by sponsor
|
7
|
3
|
|
Overall Study
Imatinib treatment failure
|
2
|
0
|
|
Overall Study
Other Reasons
|
61
|
115
|
Baseline Characteristics
All Randomized Participants
Baseline characteristics by cohort
| Measure |
Arm 2: Dasatinib (100 mg)
n=174 Participants
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
Arm 1: Imatinib (≥400 mg)
n=86 Participants
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.0 years
n=5 Participants • All Randomized Participants
|
39.5 years
n=7 Participants • All Randomized Participants
|
37.0 years
n=5 Participants • All Randomized Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants • All Randomized Participants
|
16 Participants
n=7 Participants • All Randomized Participants
|
57 Participants
n=5 Participants • All Randomized Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=5 Participants • All Randomized Participants
|
70 Participants
n=7 Participants • All Randomized Participants
|
203 Participants
n=5 Participants • All Randomized Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • All Randomized Participants
|
0 Participants
n=7 Participants • All Randomized Participants
|
0 Participants
n=5 Participants • All Randomized Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants • All Randomized Participants
|
0 Participants
n=7 Participants • All Randomized Participants
|
0 Participants
n=5 Participants • All Randomized Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
174 Participants
n=5 Participants • All Randomized Participants
|
86 Participants
n=7 Participants • All Randomized Participants
|
260 Participants
n=5 Participants • All Randomized Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • All Randomized Participants
|
0 Participants
n=7 Participants • All Randomized Participants
|
0 Participants
n=5 Participants • All Randomized Participants
|
|
Race (NIH/OMB)
Asian
|
127 Participants
n=5 Participants • All Randomized Participants
|
63 Participants
n=7 Participants • All Randomized Participants
|
190 Participants
n=5 Participants • All Randomized Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • All Randomized Participants
|
0 Participants
n=7 Participants • All Randomized Participants
|
0 Participants
n=5 Participants • All Randomized Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants • All Randomized Participants
|
3 Participants
n=7 Participants • All Randomized Participants
|
7 Participants
n=5 Participants • All Randomized Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants • All Randomized Participants
|
15 Participants
n=7 Participants • All Randomized Participants
|
51 Participants
n=5 Participants • All Randomized Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • All Randomized Participants
|
0 Participants
n=7 Participants • All Randomized Participants
|
0 Participants
n=5 Participants • All Randomized Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants • All Randomized Participants
|
5 Participants
n=7 Participants • All Randomized Participants
|
12 Participants
n=5 Participants • All Randomized Participants
|
PRIMARY outcome
Timeframe: At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib.Population: All Randomized Participants
Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals. P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (\<=4 weeks vs \>4 weeks).
Outcome measures
| Measure |
Arm 1: Imatinib (≥400 mg)
n=86 Participants
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Arm 2: Dasatinib (100 mg)
n=174 Participants
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
|---|---|---|
|
Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment
|
12.8 Percentage of Patients
Interval 6.6 to 21.7
|
28.7 Percentage of Patients
Interval 22.1 to 36.1
|
SECONDARY outcome
Timeframe: From randomization to study completion. Approximately 115 monthsPopulation: All Randomized Participants
Median Time to Major Molecular Response (MMR) is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored. Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR.
Outcome measures
| Measure |
Arm 1: Imatinib (≥400 mg)
n=86 Participants
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Arm 2: Dasatinib (100 mg)
n=174 Participants
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
|---|---|---|
|
Median Time to Major Molecular Response (MMR)
|
19.7 Months
Interval 14.2 to 26.4
|
13.9 Months
Interval 11.6 to 17.6
|
SECONDARY outcome
Timeframe: From randomization to study completion. Approximately 115 monthsPopulation: All Randomized participants
Time to Molecular Response (MR)\^4.5 is the time between randomization date and first date that MMR (or MR4.5) criteria are satisfied. Participants who do not achieve MMR (or MR4.5) will be censored. MR4.5 is defined as a 4.5-log reduction in BCR-ABL transcript from the standardized baseline (0.0032% IS, either detectable disease \<= 0.0032% BCR-ABL (IS) or undetectable disease in cDNA (in same volume used for BCR-ABL) with \>= 32,000 ABL transcripts.
Outcome measures
| Measure |
Arm 1: Imatinib (≥400 mg)
n=86 Participants
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Arm 2: Dasatinib (100 mg)
n=174 Participants
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
|---|---|---|
|
Time to Molecular Response (MR)^4.5
|
67.7 Months
Interval 55.9 to
insufficient number of participants with events to calculate via KM methodology
|
74.5 Months
Interval 67.1 to 91.8
|
SECONDARY outcome
Timeframe: From randomization to study completion. Approximately 115 monthsPopulation: All randomized participants with a progression event
PFS is the time from randomization date to progression date or death date, whichever occurs first. Participants who neither progress nor die will be censored. Progression is defined as the following, meeting the criteria for accelerated or blast crisis CML are met at any time or death from any cause during treatment. Accelerated phase of CML: * The presence of ≥15%, but \< 30% blasts in the blood or bone marrow * At least 30% blasts plus promyelocytes in the blood or bone marrow * At least 20% peripheral basophils * Thrombocytopenia (fewer than 100,000 platelets/mm3) unrelated to treatment. Blast phase of CML * At least 30% blasts in the blood or bone marrow * Extramedullary involvement (e.g., chloromas), but not hepatosplenomegaly
Outcome measures
| Measure |
Arm 1: Imatinib (≥400 mg)
n=7 Participants
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Arm 2: Dasatinib (100 mg)
n=15 Participants
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
|---|---|---|
|
Progression Free Survival (PFS)
|
NA Months
Interval 89.3 to
insufficient number of participants with events to calculate via KM methodology
|
NA Months
insufficient number of participants with events to calculate via KM methodology
|
SECONDARY outcome
Timeframe: From randomization to study completion. Approximately 115 monthsPopulation: All randomized participants who died
OS is the time from randomization date to death date. Participants who have not died will be censored on the last date they are known to be alive.
Outcome measures
| Measure |
Arm 1: Imatinib (≥400 mg)
n=5 Participants
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Arm 2: Dasatinib (100 mg)
n=11 Participants
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 89.3 to
insufficient number of participants with events to calculate via KM methodology
|
NA Months
insufficient number of participants with events to calculate via KM methodology
|
Adverse Events
Arm 1: Imatinib
Serious events: 11 serious events
Other events: 68 other events
Deaths: 1 deaths
Arm 2: Dasatinib
Serious events: 48 serious events
Other events: 159 other events
Deaths: 11 deaths
Dasatinib After Crossover From Imatinib
Serious events: 8 serious events
Other events: 42 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm 1: Imatinib
n=86 participants at risk
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Arm 2: Dasatinib
n=171 participants at risk
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
Dasatinib After Crossover From Imatinib
n=46 participants at risk
Dasatinib 100 mg tablet by mouth QD
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
2/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
2/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Diabetic retinopathy
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Visual impairment
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gingival cyst
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
2/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Salivary gland cyst
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest pain
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Sudden death
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
2/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Anal abscess
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
2/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Appendicitis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
2/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
3/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Dengue fever
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Erysipelas
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
2/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Folliculitis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
5/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.0%
6/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Tracheobronchitis
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Tuberculosis of central nervous system
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Paternal exposure timing unspecified
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia transformation
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Suicide attempt
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
11/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
2/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.2%
2/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.58%
1/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Arm 1: Imatinib
n=86 participants at risk
Imatinib ≥400 mg tablets by mouth once daily (QD) or twice daily (BID) up to 60 months.
|
Arm 2: Dasatinib
n=171 participants at risk
Dasatinib 100 mg tablet by mouth QD up to 60 months
|
Dasatinib After Crossover From Imatinib
n=46 participants at risk
Dasatinib 100 mg tablet by mouth QD
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.3%
20/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
31.0%
53/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
32.6%
15/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.3%
8/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.9%
17/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.4%
8/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.3%
20/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
24.6%
42/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
43.5%
20/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.0%
12/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.4%
40/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.7%
10/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
9/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Eyelid oedema
|
9.3%
8/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.3%
4/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
3.5%
3/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.0%
12/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.7%
4/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.2%
14/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
11/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.3%
33/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.4%
8/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
10.5%
9/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.9%
17/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
5/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
9/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
2.3%
2/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
11/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
8.1%
7/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
9/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
3.5%
3/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.3%
21/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.7%
10/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
5.8%
5/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.1%
7/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.8%
10/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
6/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.4%
16/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
15.1%
13/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.0%
29/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
26.1%
12/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
9.3%
8/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.2%
14/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
6/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
15/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin increased
|
4.7%
4/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.2%
14/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood cholesterol increased
|
1.2%
1/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.0%
12/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatine phosphokinase increased
|
12.8%
11/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
19/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.3%
2/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.2%
14/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.5%
3/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
11/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Haemoglobin decreased
|
3.5%
3/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
11/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.9%
5/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
High density lipoprotein decreased
|
2.3%
2/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.8%
10/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
9/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count decreased
|
15.1%
13/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.2%
26/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.3%
13/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
22.1%
19/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.1%
36/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
26.1%
12/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight increased
|
2.3%
2/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
5/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count decreased
|
17.4%
15/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.2%
26/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.7%
10/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.5%
3/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.0%
12/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.0%
6/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.2%
14/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.6%
10/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.8%
10/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.8%
5/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.3%
9/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.9%
18/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.8%
27/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.0%
6/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
6/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.7%
8/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.7%
4/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
5/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.7%
8/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.8%
11/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
3/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.5%
3/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
11/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.1%
7/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.8%
10/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
7.0%
6/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
11/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
3.5%
3/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.4%
40/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.0%
6/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
8.1%
7/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.3%
4/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.2%
1/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
3/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
18/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
4/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
11/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.0%
6/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.0%
24/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.6%
9/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.3%
8/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.3%
21/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
5.8%
5/86 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
11/171 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.5%
3/46 • From first dose date up to 30 days after last dose of study therapy. Assessed from Sept. 2012 to Nov. 2017 (approximately 62 months) All cause mortality is from the time of randomization to the end of study. Approximately 115 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER