Trial Outcomes & Findings for Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias (NCT NCT00261846)
NCT ID: NCT00261846
Last Updated: 2017-07-27
Results Overview
DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
571 participants
Primary outcome timeframe
Part 1 Baseline up to Day 28
Results posted on
2017-07-27
Participant Flow
Participant milestones
| Measure |
Bosutinib 400 mg (Part 1)
Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line (CP2L) chronic myelogenous leukemia (CML) Part 2 of the study.
|
Bosutinib 500 mg (Part 1)
Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
|
Bosutinib 600 mg (Part 1)
Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase (AP) CML Part 2 of the study.
|
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
AP-CML Total (Part 2)
All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
|
BP-CML Total (Part 2)
All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1: Part 1 (Dose Escalation)
STARTED
|
3
|
3
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Part 1 (Dose Escalation)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Part 1 (Dose Escalation)
NOT COMPLETED
|
3
|
3
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Part 2 (Efficacy)
STARTED
|
0
|
0
|
0
|
195
|
89
|
5
|
38
|
50
|
26
|
79
|
64
|
24
|
|
Period 2: Part 2 (Efficacy)
COMPLETED
|
0
|
0
|
0
|
60
|
39
|
3
|
16
|
21
|
12
|
30
|
15
|
1
|
|
Period 2: Part 2 (Efficacy)
NOT COMPLETED
|
0
|
0
|
0
|
135
|
50
|
2
|
22
|
29
|
14
|
49
|
49
|
23
|
Reasons for withdrawal
| Measure |
Bosutinib 400 mg (Part 1)
Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line (CP2L) chronic myelogenous leukemia (CML) Part 2 of the study.
|
Bosutinib 500 mg (Part 1)
Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
|
Bosutinib 600 mg (Part 1)
Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase (AP) CML Part 2 of the study.
|
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
AP-CML Total (Part 2)
All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
|
BP-CML Total (Part 2)
All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1: Part 1 (Dose Escalation)
Continued in to Part 2
|
3
|
3
|
12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2: Part 2 (Efficacy)
Discontinuation of study by sponsor
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 2: Part 2 (Efficacy)
Withdrawal by Subject
|
0
|
0
|
0
|
9
|
8
|
1
|
3
|
3
|
0
|
2
|
0
|
0
|
|
Period 2: Part 2 (Efficacy)
Lost to Follow-up
|
0
|
0
|
0
|
12
|
4
|
0
|
4
|
0
|
1
|
4
|
4
|
0
|
|
Period 2: Part 2 (Efficacy)
Other
|
0
|
0
|
0
|
15
|
4
|
0
|
1
|
5
|
4
|
4
|
0
|
0
|
|
Period 2: Part 2 (Efficacy)
Death
|
0
|
0
|
0
|
37
|
7
|
1
|
10
|
12
|
3
|
30
|
44
|
22
|
|
Period 2: Part 2 (Efficacy)
Extension study
|
0
|
0
|
0
|
61
|
27
|
0
|
4
|
9
|
5
|
9
|
1
|
1
|
Baseline Characteristics
Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
Baseline characteristics by cohort
| Measure |
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
AP-CML Total (Part 2)
n=79 Participants
All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
|
BP-CML Total (Part 2)
n=64 Participants
All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Total
n=570 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Age, Customized
Between 18 and 44 years
|
73 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
10 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
29 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
179 Participants
n=62 Participants
|
|
Age, Customized
Between 45 and 64 years
|
86 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
25 Participants
n=40 Participants
|
7 Participants
n=8 Participants
|
272 Participants
n=62 Participants
|
|
Age, Customized
>=65 years
|
36 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
10 Participants
n=40 Participants
|
11 Participants
n=8 Participants
|
119 Participants
n=62 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
22 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
270 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
42 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
300 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: Part 1 Baseline up to Day 28Population: Safety population included all participants who received at least 1 dose of study medication.
DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=12 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT)
|
—
|
0 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part 1 Baseline up to Day 28Population: Safety population included all participants who received at least 1 dose of study medication
MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1). NA = not estimable.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=12 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
—
|
NA mg
MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2.
|
NA mg
MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2.
|
NA mg
MTD was not achieved since no more than 1 DLT was observed in any cohort. At the 600mg dose level, 1 DLT and several treatment related grade 2 toxicities were observed, thus, Bosutinib 500 mg was selected as the recommended dose for part 2.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=12 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Part 1
|
—
|
89.3 nanogram per milliliter (ng/mL)
Standard Deviation 50.0
|
101.0 nanogram per milliliter (ng/mL)
Standard Deviation 35.6
|
120.0 nanogram per milliliter (ng/mL)
Standard Deviation 40.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1Population: Evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline efficacy assessment.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=12 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
|
—
|
4.00 hours (hrs)
Interval 3.33 to 48.08
|
6.00 hours (hrs)
Interval 6.0 to 6.0
|
4.00 hours (hrs)
Interval 2.17 to 49.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. NA = not estimable.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=2 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=8 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2) - Part 1
|
—
|
22.91 hrs
Standard Deviation 3.39
|
22.46 hrs
Standard Deviation 1.73
|
22.24 hrs
Standard Deviation 5.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.
AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=12 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1
|
—
|
1850 ng*hr/mL
Standard Deviation 710
|
2060 ng*hr/mL
Standard Deviation 483
|
2340 ng*hr/mL
Standard Deviation 1140
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. NA = not estimable.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=2 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=8 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve (AUC) - Part 1
|
—
|
2530 ng*hr/mL
Standard Deviation 1160
|
2760 ng*hr/mL
Standard Deviation 687
|
2420 ng*hr/mL
Standard Deviation 457
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. NA = not estimable.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=2 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=8 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) - Part 1
|
—
|
177 liter per hour (L/hr)
Standard Deviation 81.3
|
189 liter per hour (L/hr)
Standard Deviation 47.5
|
258 liter per hour (L/hr)
Standard Deviation 61.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=8 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) - Part 1
|
—
|
6050 liter
Standard Deviation 3550
|
6080 liter
Standard Deviation 1230
|
8540 liter
Standard Deviation 3820
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
Maximum plasma concentration over 24 hours at steady state (ss), on Day 15.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=10 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1
|
—
|
146 ng/mL
Standard Deviation 20.0
|
200 ng/mL
Standard Deviation 11.9
|
208 ng/mL
Standard Deviation 73.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.
Time to reach maximum observed plasma concentration over 24 hours at steady state (ss), on Day 15.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=12 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1
|
—
|
4.05 hrs
Interval 3.08 to 6.08
|
6.05 hrs
Interval 4.0 to 8.0
|
6.00 hrs
Interval 2.83 to 11.08
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life over 24 hours at steady state (ss), on Day 15 was calculated.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=7 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Decay Half-Life at Steady State (t1/2,ss) - Part 1
|
—
|
45.96 hrs
Standard Deviation 32.30
|
21.71 hrs
Standard Deviation 4.64
|
25.87 hrs
Standard Deviation 24.85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC over 24 hours at steady state (ss), on Day 15 was calculated.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=9 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1
|
—
|
2720 ng*hr/mL
Standard Deviation 442
|
3650 ng*hr/mL
Standard Deviation 425
|
3630 ng*hr/mL
Standard Deviation 1270
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent oral clearence over 24 hours at steady state (ss), on Day 15 was calculated.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=9 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance at Steady State (CL/F,ss) - Part 1
|
—
|
150 L/hr
Standard Deviation 23.2
|
138 L/hr
Standard Deviation 16.6
|
185 L/hr
Standard Deviation 66.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 and Day 15Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
R=accumulation ratio (AUCss on Day 15/AUC0-24 on Day 1)
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=9 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (R)
|
—
|
3.1 ratio
Standard Deviation 1.4
|
2.8 ratio
Standard Deviation 0.8
|
2.5 ratio
Standard Deviation 0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.
CyR is based on the prevalence of Ph+ cells. Major cytogenetic response was categorized as either CCyR or partial CyR (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or less than (\<) 1% positive cells from at least 200 cells analyzed from fluorescent in situ hybridization (FISH). PCyR was achieved when 1 to 35% Ph+ cells were present.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=182 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With MCyR at Week 24 in Chronic Phase Second-line Imatinib Resistant CML Population - Part 2
|
—
|
35.7 percentage of participants
Interval 28.8 to 43.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, 48 and the end of active treatment phase of Part 1 (Week 52)Population: Cytogenetic evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline cytogenetic assessment.
Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or \<1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=12 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Major Cytogenetic Response (MCyR) - Part 1
|
—
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
50.0 percentage of participants
Interval 21.1 to 78.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 48 and the end of the active treatment phase of Part 1 (Week 52)Population: Data was not summarized since inadequate data included the issue that molecular transcript analyses could not be performed, because of potential sample quality issues due to time required to transport the specimens from the few investigational sites to the central laboratory.
bcr-Abl is a protein resulting from the transcription of the Philadelphia chromosome following 9:22 chromosomal translocation, and phosphorylation inhibition of which correlates with inhibition of tumor cell growth.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 (pre-dose) on Day 1 (Baseline)Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the cluster of differentiation 3 (CD3+) (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using fluorescent activated cell sorter (FACS) flow cytometry.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=2 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=10 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phosphorylation Inhibition of Crk Like (CrkL) Protein at Baseline - Part 1
|
—
|
457075 mol/100 cells
Standard Deviation 559841.90
|
297967.33 mol/100 cells
Standard Deviation 171643.30
|
397795.40 mol/100 cells
Standard Deviation 552536.90
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15Population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' signifies number of participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time points for each arm group respectively.
CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the CD3+ (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using FACS flow cytometry. NA = not estimable.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=1 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=9 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1
Day 1: post-dose (n=1, 1, 9)
|
—
|
-34.66 percent change
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
287.52 percent change
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
97.79 percent change
Standard Deviation 283.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1
Day 8: pre-dose (n=1, 1, 9)
|
—
|
562.48 percent change
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
170.83 percent change
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
3.88 percent change
Standard Deviation 128.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1
Day 8: post-dose (n=1, 1, 9)
|
—
|
528.62 percent change
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
429.79 percent change
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
143.57 percent change
Standard Deviation 289.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1
Day 15: pre-dose (n=1, 2, 7)
|
—
|
177.87 percent change
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
-44.64 percent change
Standard Deviation 8.56
|
119.23 percent change
Standard Deviation 170.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1
Day 15: post-dose (n=1, 3, 7)
|
—
|
-49.85 percent change
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
-21.13 percent change
Standard Deviation 57.91
|
138.45 percent change
Standard Deviation 278.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L) or Year 5 (CP2L)Population: Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.
CyR is based on the prevalence of Ph+ cells. MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or \<1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=182 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=80 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=36 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=45 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Chronic Phase Third-line CML Population - Part 2
|
58.8 percentage of participants
Interval 51.3 to 66.0
|
61.3 percentage of participants
Interval 49.7 to 71.9
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
38.9 percentage of participants
Interval 23.1 to 56.5
|
42.2 percentage of participants
Interval 27.7 to 57.9
|
38.5 percentage of participants
Interval 20.2 to 59.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first MCyR to loss of MCyR or censoring, assessed every 12 weeks up to 2 years and then every 24 weeks thereafter up to Year 5Population: Subgroup of participants from evaluable population who had MCyR.
MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or \<1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. The Kaplan-Meier probability of retaining an attained/maintained MCyR at Year 5 is reported. Median durations were not reached as of the minimum follow-up. Duration of response in weeks =(date of confirmed loss of first attained response or last valid cytogenetic assessment for those censored - date of first attained response)/7.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=107 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=49 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimate of Retaining an Attained/Maintained Major Cytogenetic Response (MCyR) at Year 5 in Chronic Phase Second-line CML - Part 2
|
—
|
67.2 % probability of retaining MCyR
Interval 56.8 to 75.6
|
79.8 % probability of retaining MCyR
Interval 63.1 to 89.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 5Population: Cytogenetic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline cytogenetic assessment.
MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or \<1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response. Time to response in weeks equals (=) (event date minus (-) first dose date plus (+) 1)divided (/)7, where the event date is the non-missing date of the first attained response for responders only.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=107 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=49 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Achieve Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML for Responders Only - Part 2
|
—
|
12.3 weeks
Interval 12.1 to 24.0
|
12.1 weeks
Interval 12.0 to 12.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)Population: Subgroup of participants from evaluable population who had confirmed CHR.
Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes \<5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10\^9 per liter (/L) , platelets ≥100×10\^9/L \& \<450×10\^9/L, \<20% basophils in blood \& no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (ADV only \& applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. The Kaplan-Meier estimate of maintaining CHR at the end of minimum follow-up is presented (CP2L: Year 5; CP3L \& ADV: Year 4). NA = not estimable. NA = not estimable.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=19 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=169 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=76 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=4 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=37 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=17 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=7 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=9 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=1 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=2 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimate of Maintaining Complete Hematologic Response (CHR) at Year 4 (CP3L and ADV) or Year 5 (CP2L) - Part 2
|
61.9 % estimate of maintaining response
Interval 33.6 to 81.0
|
61.5 % estimate of maintaining response
Interval 52.9 to 69.1
|
78.2 % estimate of maintaining response
Interval 64.4 to 87.1
|
50.0 % estimate of maintaining response
Interval 5.8 to 84.5
|
56.5 % estimate of maintaining response
Interval 30.9 to 75.8
|
69.9 % estimate of maintaining response
Interval 49.7 to 83.3
|
47.1 % estimate of maintaining response
Interval 20.7 to 69.7
|
64.3 % estimate of maintaining response
Interval 15.1 to 90.2
|
NA % estimate of maintaining response
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
|
NA % estimate of maintaining response
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
|
100 % estimate of maintaining response
Interval to 100.0
Lower limit of the 95% CI was NA due to insufficient patients and/or follow-up.
|
SECONDARY outcome
Timeframe: From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)Population: Subgroup of participants from evaluable population who had confirmed CHR.
Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes less than (\<)5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10\^9 per liter (/L) , platelets \<450×10\^9/L, platelets ≥100×10\^9/L, \<20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. NA = not estimable.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=19 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=169 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=76 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=4 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=37 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=17 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=7 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=9 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=1 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=2 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Complete Hematologic Response (CHR) - Part 2
|
NA weeks
Interval 56.0 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
NA weeks
Interval 297.7 to
KM estimate at Year 5 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
350.4 weeks
Interval 350.4 to
The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
NA weeks
Interval 9.6 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
NA weeks
Interval 38.3 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
295.6 weeks
Interval 289.0 to
The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
138.0 weeks
Interval 24.0 to
The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
NA weeks
Interval 102.0 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
28.6 weeks
Interval 20.1 to
The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
40.0 weeks
95% CIs were NA due to insufficient patients and/or follow-up.
|
NA weeks
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
|
SECONDARY outcome
Timeframe: Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)Population: Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment - responders only.
The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response for responders only.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=19 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=169 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=76 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=4 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=37 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=17 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=7 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=9 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=1 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=2 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Achieve Complete Hematologic Response (CHR) for Responders Only - Part 2
|
2.4 weeks
Interval 1.1 to 3.3
|
2.0 weeks
Interval 1.1 to 2.1
|
1.3 weeks
Interval 1.1 to 2.1
|
1.6 weeks
Interval 1.1 to 2.1
|
1.2 weeks
Interval 1.1 to 3.0
|
1.3 weeks
Interval 1.1 to 2.3
|
12.1 weeks
Interval 8.1 to 24.0
|
12.1 weeks
Interval 4.3 to 72.0
|
8.0 weeks
Interval 4.0 to 13.0
|
12.1 weeks
95% CIs were NA due to insufficient patients and/or follow-up.
|
10.0 weeks
Interval 4.0 to 13.0
|
SECONDARY outcome
Timeframe: Years 1, 2, 3, 4, and 5 (CP2L only)Population: All-treated population included all enrolled participants who received at least one dose of study medication.
The cumulative incidence of on-treatment progression or death adjusting for the competing risk of treatment discontinuation without the event. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4. 95% confidence intervals were calculated using Gray's method. NA = not estimable. One year = 12 months.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=49 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=30 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=36 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=28 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cumulative Incidence of Progression/Death - Part 2
Year 3
|
34.6 percentage of participants
Interval 20.4 to 58.7
|
22.1 percentage of participants
Interval 16.9 to 28.7
|
9.0 percentage of participants
Interval 4.6 to 17.4
|
40.0 percentage of participants
Interval 13.7 to 100.0
|
23.7 percentage of participants
Interval 13.4 to 41.9
|
16.0 percentage of participants
Interval 8.5 to 30.2
|
44.9 percentage of participants
Interval 32.9 to 61.2
|
26.7 percentage of participants
Interval 14.7 to 48.3
|
50.0 percentage of participants
Interval 36.1 to 69.3
|
75.0 percentage of participants
Interval 60.6 to 92.9
|
58.3 percentage of participants
Interval 41.6 to 81.8
|
|
Cumulative Incidence of Progression/Death - Part 2
Year 2
|
30.8 percentage of participants
Interval 17.3 to 54.8
|
19.0 percentage of participants
Interval 14.2 to 25.4
|
6.7 percentage of participants
Interval 3.1 to 14.6
|
40.0 percentage of participants
Interval 13.7 to 100.0
|
23.7 percentage of participants
Interval 13.4 to 41.9
|
14.0 percentage of participants
Interval 7.0 to 27.8
|
42.9 percentage of participants
Interval 31.0 to 59.2
|
23.3 percentage of participants
Interval 12.2 to 44.6
|
50.0 percentage of participants
Interval 36.1 to 69.3
|
71.4 percentage of participants
Interval 56.5 to 90.3
|
58.3 percentage of participants
Interval 41.6 to 81.8
|
|
Cumulative Incidence of Progression/Death - Part 2
Year 1
|
23.1 percentage of participants
Interval 11.4 to 46.6
|
10.8 percentage of participants
Interval 7.2 to 16.1
|
4.5 percentage of participants
Interval 1.7 to 11.7
|
20.0 percentage of participants
Interval 3.5 to 100.0
|
23.7 percentage of participants
Interval 13.4 to 41.9
|
12.0 percentage of participants
Interval 5.7 to 25.4
|
28.6 percentage of participants
Interval 18.4 to 44.5
|
20.0 percentage of participants
Interval 9.8 to 40.9
|
47.2 percentage of participants
Interval 33.4 to 66.7
|
71.4 percentage of participants
Interval 56.5 to 90.3
|
58.3 percentage of participants
Interval 41.6 to 81.8
|
|
Cumulative Incidence of Progression/Death - Part 2
Year 4
|
34.6 percentage of participants
Interval 20.4 to 58.7
|
22.6 percentage of participants
Interval 17.4 to 29.3
|
9.0 percentage of participants
Interval 4.6 to 17.4
|
40.0 percentage of participants
Interval 13.7 to 100.0
|
23.7 percentage of participants
Interval 13.4 to 41.9
|
16.0 percentage of participants
Interval 8.5 to 30.2
|
44.9 percentage of participants
Interval 32.9 to 61.2
|
26.7 percentage of participants
Interval 14.7 to 48.3
|
50.0 percentage of participants
Interval 36.1 to 69.3
|
75.0 percentage of participants
Interval 60.6 to 92.9
|
58.3 percentage of participants
Interval 41.6 to 81.8
|
|
Cumulative Incidence of Progression/Death - Part 2
Year 5
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
23.1 percentage of participants
Interval 17.9 to 29.8
|
10.1 percentage of participants
Interval 5.4 to 18.8
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
SECONDARY outcome
Timeframe: Years 1, 2, 3, 4, and 5 (CP2L only)Population: All-treated population included all enrolled participants who received at least one dose of study medication.
PFS was based on Kaplan-Meier method. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4. NA = not estimable. One year = 12 months
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=49 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=30 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=36 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=28 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) - Part 2
|
NA Months
Interval 14.1 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. Upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
NA Months
KM estimate at Year 5 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
|
81.5 Months
Interval 81.5 to
Upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
NA Months
Interval 0.9 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. Upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
NA Months
Interval 11.1 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. Upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
NA Months
Interval 68.5 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. Upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
20.4 Months
Interval 11.8 to
Upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
35.4 Months
Interval 14.6 to
Upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
|
7.9 Months
Interval 4.0 to 10.1
|
1.8 Months
Interval 0.9 to 5.5
|
1.5 Months
Interval 0.7 to 3.8
|
SECONDARY outcome
Timeframe: Years 1, 2, 3, 4, and 5 (CP2L only)Population: All-treated population included all enrolled participants who received at least 1 dose of study medication.
OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored. NA = not estimable. One year = 12 months.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=49 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=30 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=36 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=28 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Estimate of Overall Survival (OS) - Part 2
Year 1
|
96.2 percentage of participants
Interval 75.7 to 99.4
|
96.3 percentage of participants
Interval 92.5 to 98.2
|
98.9 percentage of participants
Interval 92.1 to 99.8
|
100 percentage of participants
Interval 100.0 to 100.0
|
85.8 percentage of participants
Interval 69.2 to 93.8
|
91.8 percentage of participants
Interval 79.7 to 96.6
|
81.3 percentage of participants
Interval 67.2 to 89.8
|
72.9 percentage of participants
Interval 53.0 to 85.4
|
44.3 percentage of participants
Interval 27.4 to 59.9
|
39.3 percentage of participants
Interval 21.7 to 56.5
|
16.7 percentage of participants
Interval 5.2 to 33.7
|
|
Kaplan-Meier Estimate of Overall Survival (OS) - Part 2
Year 5
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
80.6 percentage of participants
Interval 73.6 to 85.9
|
88.4 percentage of participants
Interval 76.6 to 94.5
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
NA percentage of participants
In Part 2 subjects in CP3L and ADV treatment groups were only evaluated up to Year 4.
|
|
Kaplan-Meier Estimate of Overall Survival (OS) - Part 2
Year 3
|
86.5 percentage of participants
Interval 62.9 to 95.6
|
84.1 percentage of participants
Interval 77.8 to 88.7
|
93.0 percentage of participants
Interval 83.9 to 97.1
|
80.0 percentage of participants
Interval 20.4 to 96.9
|
66.1 percentage of participants
Interval 44.5 to 80.9
|
83.3 percentage of participants
Interval 69.3 to 91.3
|
70.1 percentage of participants
Interval 54.7 to 81.1
|
45.1 percentage of participants
Interval 25.4 to 63.0
|
41.3 percentage of participants
Interval 24.9 to 57.0
|
16.7 percentage of participants
Interval 5.6 to 32.9
|
8.3 percentage of participants
Interval 1.4 to 23.3
|
|
Kaplan-Meier Estimate of Overall Survival (OS) - Part 2
Year 2
|
92.3 percentage of participants
Interval 72.6 to 98.0
|
88.2 percentage of participants
Interval 82.7 to 92.1
|
97.7 percentage of participants
Interval 91.0 to 99.4
|
80.0 percentage of participants
Interval 20.4 to 96.9
|
79.7 percentage of participants
Interval 62.0 to 89.8
|
83.3 percentage of participants
Interval 69.3 to 91.3
|
72.7 percentage of participants
Interval 57.6 to 83.1
|
59.0 percentage of participants
Interval 39.2 to 74.3
|
41.3 percentage of participants
Interval 24.9 to 57.0
|
25.0 percentage of participants
Interval 11.1 to 41.8
|
8.3 percentage of participants
Interval 1.4 to 23.3
|
|
Kaplan-Meier Estimate of Overall Survival (OS) - Part 2
Year 4
|
86.5 percentage of participants
Interval 62.9 to 95.6
|
81.5 percentage of participants
Interval 74.7 to 86.6
|
93.0 percentage of participants
Interval 83.9 to 97.1
|
80.0 percentage of participants
Interval 20.4 to 96.9
|
66.1 percentage of participants
Interval 44.5 to 80.9
|
79.3 percentage of participants
Interval 63.1 to 89.0
|
65.7 percentage of participants
Interval 48.6 to 78.3
|
45.1 percentage of participants
Interval 25.4 to 63.0
|
20.7 percentage of participants
Interval 2.0 to 53.2
|
16.7 percentage of participants
Interval 5.6 to 32.9
|
8.3 percentage of participants
Interval 1.4 to 23.3
|
SECONDARY outcome
Timeframe: Years 1, 2, 3, 4, and 5 (CP2L only)Population: All-treated population included all enrolled participants who received at least 1 dose of study medication.
OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored. NA = not estimable. One year = 12 months.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=49 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=30 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=36 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=28 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) - Part 2
|
NA Months
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
|
NA Months
KM estimate at Year 5 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
|
81.5 Months
Interval 81.5 to
The upper 95% CI was NA due to insufficient patients and/or follow-up.
|
NA Months
Interval 21.0 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper 95% CI was NA due to insufficient patients and/or follow-up.
|
NA Months
Interval 34.4 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper 95% CI was NA due to insufficient patients and/or follow-up.
|
NA Months
Interval 68.5 to
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper 95% CI was NA due to insufficient patients and/or follow-up.
|
NA Months
KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
|
33.4 Months
Interval 14.6 to
The upper 95% CI was NA due to insufficient patients and/or follow-up.
|
11.2 Months
Interval 9.4 to
The upper 95% CI was NA due to insufficient patients and/or follow-up.
|
8.9 Months
Interval 4.1 to 17.4
|
3.6 Months
Interval 1.3 to 7.6
|
SECONDARY outcome
Timeframe: Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)Population: Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.
Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells ≤ institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes \<5% in blood, absolute neutrophil count ≥ 1.0×10\^9/L , platelets \<450×10\^9/L, platelets ≥100×10\^9/L, \<20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed).
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=25 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=194 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=49 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=43 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=29 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=34 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=22 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Confirmed Complete Hematologic Response (CHR) - Part 2
|
76.0 percentage of participants
Interval 54.9 to 90.6
|
87.1 percentage of participants
Interval 81.6 to 91.5
|
85.4 percentage of participants
Interval 76.3 to 92.0
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
68.4 percentage of participants
Interval 51.3 to 82.5
|
75.5 percentage of participants
Interval 61.1 to 86.7
|
39.5 percentage of participants
Interval 25.0 to 55.6
|
24.1 percentage of participants
Interval 10.3 to 43.5
|
26.5 percentage of participants
Interval 12.9 to 44.4
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
9.1 percentage of participants
Interval 1.1 to 29.2
|
SECONDARY outcome
Timeframe: Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 1 yearPopulation: Hematologic evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline hematologic assessment.
OHR included CHR, no evidence of leukemia (≤5% bone marrow blasts, no peripheral blood blasts or promyelocytes, \<5% myelocytes + metamyelocytes in blood, white blood cells ≤ institutional upper limit of normal, 450x10\^9/L \> platelets \> 20x10\^9/L, absolute neutrophil count ≥0.5x10\^9/L, \<20% basophils in blood, no extramedullary involvement \[including liver or spleen\]), minor hematologic response (acute lymphoblastic leukemia \[ALL\] patients only, defined as \<15% blasts in marrow \& blood, \<30% blasts + promyelocytes in marrow \& blood, \<20% basophils in peripheral blood \& no extramedullary disease other than spleen \& liver) or return to chronic phase (AP/BP participants, defined as \<15% blasts in both peripheral blood \&bone marrow, \<30% blasts + promyelocytes in both peripheral blood \& bone marrow, \<20% basophils in both peripheral blood \& bone marrow, no extramedullary Involvement other than liver or spleen). Participants had to meet at least 1 criterion.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=43 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=29 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=34 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=22 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2
|
—
|
67.4 percentage of participants
Interval 51.5 to 80.9
|
41.4 percentage of participants
Interval 23.5 to 61.1
|
38.2 percentage of participants
Interval 22.2 to 56.4
|
15.4 percentage of participants
Interval 4.4 to 34.9
|
9.1 percentage of participants
Interval 1.1 to 29.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to follow up visit (30 days after last dose of study treatment)Population: Safety population included all participants who receive at least one dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=49 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=30 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=36 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=28 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
100.0 percentage of participants
|
99.5 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
97.2 percentage of participants
|
100.0 percentage of participants
|
95.8 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
19.2 percentage of participants
|
41.5 percentage of participants
|
38.2 percentage of participants
|
20.0 percentage of participants
|
39.5 percentage of participants
|
38.0 percentage of participants
|
49.0 percentage of participants
|
63.3 percentage of participants
|
55.6 percentage of participants
|
60.7 percentage of participants
|
70.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to follow-up visit (30 days after last dose of study treatment)Population: Safety population included all participants who receive at least one dose of study medication.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. The event did not necessarily have a causal relationship with the treatment. PCI AEs included anemia, alanine aminotranferase (ALT), aspartate aminotransferase (AST), cardiac, diarrhea, edema, effusion, gastrointestinal, hemorrhage, hypersensitivity, hypertension, infection, liver, myelosuppression, nausea, neutropenia, rash, renal, thrombocytopenia, vomiting, and vascular events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates. NA = not estimable.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=79 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=64 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Anaemia
|
61.0 days
Interval 6.0 to 335.0
|
14.0 days
Interval 1.0 to 1373.0
|
36.0 days
Interval 2.0 to 688.0
|
38.0 days
Interval 38.0 to 38.0
|
19.0 days
Interval 1.0 to 284.0
|
13.0 days
Interval 6.0 to 271.0
|
12.5 days
Interval 1.0 to 502.0
|
4.0 days
Interval 1.0 to 52.0
|
7.0 days
Interval 1.0 to 20.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Diarrhoea
|
1.0 days
Interval 1.0 to 289.0
|
1.0 days
Interval 1.0 to 2174.0
|
2.0 days
Interval 1.0 to 1121.0
|
2.0 days
Interval 1.0 to 59.0
|
2.0 days
Interval 1.0 to 189.0
|
2.0 days
Interval 1.0 to 413.0
|
2.0 days
Interval 1.0 to 910.0
|
2.0 days
Interval 1.0 to 211.0
|
3.0 days
Interval 1.0 to 500.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Neutropenia
|
26.0 days
Interval 7.0 to 92.0
|
23.0 days
Interval 1.0 to 506.0
|
15.0 days
Interval 1.0 to 337.0
|
23.0 days
Interval 13.0 to 70.0
|
14.5 days
Interval 4.0 to 81.0
|
21.0 days
Interval 3.0 to 504.0
|
8.0 days
Interval 1.0 to 252.0
|
5.0 days
Interval 1.0 to 52.0
|
6.5 days
Interval 5.0 to 8.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Renal events
|
56.5 days
Interval 29.0 to 84.0
|
27.0 days
Interval 1.0 to 831.0
|
190.0 days
Interval 7.0 to 903.0
|
1167.0 days
Interval 1167.0 to 1167.0
|
162.0 days
Interval 21.0 to 299.0
|
11.0 days
Interval 1.0 to 203.0
|
26.0 days
Interval 3.0 to 1403.0
|
9.0 days
Interval 1.0 to 27.0
|
12.0 days
Interval 12.0 to 12.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Vomiting
|
7.0 days
Interval 1.0 to 39.0
|
1.0 days
Interval 1.0 to 165.0
|
1.0 days
Interval 1.0 to 36.0
|
NA days
No events therefore duration not available.
|
1.0 days
Interval 1.0 to 141.0
|
2.0 days
Interval 1.0 to 59.0
|
1.0 days
Interval 1.0 to 128.0
|
1.0 days
Interval 1.0 to 41.0
|
1.5 days
Interval 1.0 to 9.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Vascular events
|
10.0 days
Interval 10.0 to 10.0
|
3.5 days
Interval 1.0 to 277.0
|
6.0 days
Interval 1.0 to 59.0
|
NA days
No events therefore duration not available.
|
10.5 days
Interval 3.0 to 18.0
|
1.5 days
Interval 1.0 to 266.0
|
2.0 days
Interval 1.0 to 22.0
|
1.0 days
Interval 1.0 to 14.0
|
1.0 days
Interval 1.0 to 19.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Hypersensitivity
|
5.0 days
Interval 1.0 to 9.0
|
9.0 days
Interval 6.0 to 38.0
|
8.0 days
Interval 7.0 to 9.0
|
NA days
No events therefore duration not available.
|
7.0 days
Interval 1.0 to 28.0
|
6.0 days
Interval 1.0 to 15.0
|
1.0 days
Interval 1.0 to 1.0
|
NA days
No events therefore duration not available.
|
NA days
No events therefore duration not available.
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Nausea
|
2.0 days
Interval 1.0 to 42.0
|
2.0 days
Interval 1.0 to 972.0
|
4.0 days
Interval 1.0 to 446.0
|
4.0 days
Interval 1.0 to 7.0
|
2.0 days
Interval 1.0 to 168.0
|
14.0 days
Interval 1.0 to 713.0
|
6.0 days
Interval 1.0 to 247.0
|
6.5 days
Interval 1.0 to 274.0
|
9.0 days
Interval 1.0 to 31.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Cardiac events
|
1.0 days
Interval 1.0 to 1.0
|
11.0 days
Interval 1.0 to 1428.0
|
6.0 days
Interval 1.0 to 657.0
|
NA days
No events therefore duration not available.
|
7.5 days
Interval 1.0 to 842.0
|
22.0 days
Interval 1.0 to 907.0
|
14.0 days
Interval 1.0 to 1536.0
|
3.0 days
Interval 1.0 to 19.0
|
1.5 days
Interval 1.0 to 2.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Oedema
|
28.0 days
Interval 3.0 to 316.0
|
29.0 days
Interval 1.0 to 1416.0
|
81.5 days
Interval 1.0 to 1807.0
|
4.0 days
Interval 1.0 to 52.0
|
1.0 days
Interval 1.0 to 455.0
|
12.5 days
Interval 2.0 to 774.0
|
88.5 days
Interval 2.0 to 670.0
|
11.0 days
Interval 1.0 to 214.0
|
5.0 days
Interval 1.0 to 8.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Rash
|
12.5 days
Interval 1.0 to 150.0
|
15.0 days
Interval 1.0 to 1622.0
|
13.0 days
Interval 1.0 to 965.0
|
17.0 days
Interval 7.0 to 52.0
|
12.0 days
Interval 1.0 to 348.0
|
19.0 days
Interval 1.0 to 1612.0
|
13.0 days
Interval 1.0 to 428.0
|
7.5 days
Interval 1.0 to 218.0
|
12.0 days
Interval 1.0 to 33.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Thrombocytopenia
|
21.5 days
Interval 6.0 to 350.0
|
22.0 days
Interval 1.0 to 1762.0
|
15.0 days
Interval 1.0 to 1541.0
|
38.5 days
Interval 14.0 to 120.0
|
15.0 days
Interval 1.0 to 336.0
|
15.0 days
Interval 2.0 to 420.0
|
11.5 days
Interval 1.0 to 889.0
|
5.0 days
Interval 1.0 to 176.0
|
9.0 days
Interval 3.0 to 43.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Hypertension
|
NA days
No events therefore duration not available.
|
16.0 days
Interval 1.0 to 1343.0
|
1.0 days
Interval 1.0 to 1659.0
|
NA days
No events therefore duration not available.
|
7.0 days
Interval 7.0 to 7.0
|
1.0 days
Interval 1.0 to 418.0
|
5.0 days
Interval 1.0 to 204.0
|
NA days
No events therefore duration not available.
|
2.0 days
Interval 2.0 to 2.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Gastrointestinal events
|
2.0 days
Interval 1.0 to 289.0
|
1.0 days
Interval 1.0 to 2174.0
|
2.0 days
Interval 1.0 to 1121.0
|
2.0 days
Interval 1.0 to 59.0
|
2.0 days
Interval 1.0 to 189.0
|
2.0 days
Interval 1.0 to 713.0
|
2.0 days
Interval 1.0 to 910.0
|
3.0 days
Interval 1.0 to 274.0
|
4.0 days
Interval 1.0 to 500.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Haemorrhage
|
7.5 days
Interval 1.0 to 58.0
|
10.0 days
Interval 1.0 to 862.0
|
16.0 days
Interval 1.0 to 131.0
|
23.0 days
Interval 23.0 to 23.0
|
4.0 days
Interval 1.0 to 11.0
|
27.5 days
Interval 1.0 to 190.0
|
6.0 days
Interval 1.0 to 147.0
|
4.0 days
Interval 1.0 to 28.0
|
3.5 days
Interval 1.0 to 21.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Liver
|
21.0 days
Interval 3.0 to 82.0
|
29.0 days
Interval 1.0 to 803.0
|
16.0 days
Interval 1.0 to 344.0
|
8.0 days
Interval 8.0 to 8.0
|
25.5 days
Interval 7.0 to 236.0
|
9.0 days
Interval 5.0 to 136.0
|
16.0 days
Interval 1.0 to 252.0
|
8.0 days
Interval 1.0 to 441.0
|
5.0 days
Interval 1.0 to 9.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
ALT
|
21.0 days
Interval 4.0 to 42.0
|
29.0 days
Interval 1.0 to 775.0
|
15.0 days
Interval 1.0 to 344.0
|
NA days
No events therefore duration not available.
|
21.5 days
Interval 7.0 to 236.0
|
8.0 days
Interval 5.0 to 87.0
|
21.5 days
Interval 7.0 to 252.0
|
7.5 days
Interval 1.0 to 41.0
|
3.0 days
Interval 1.0 to 5.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
AST
|
15.0 days
Interval 8.0 to 21.0
|
29.0 days
Interval 1.0 to 803.0
|
13.5 days
Interval 1.0 to 330.0
|
NA days
No events therefore duration not available.
|
18.0 days
Interval 14.0 to 22.0
|
8.5 days
Interval 8.0 to 22.0
|
14.0 days
Interval 1.0 to 188.0
|
2.0 days
Interval 2.0 to 2.0
|
5.0 days
Interval 5.0 to 5.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Effusion
|
20.0 days
Interval 5.0 to 258.0
|
18.5 days
Interval 1.0 to 1428.0
|
29.0 days
Interval 5.0 to 657.0
|
79.5 days
Interval 14.0 to 421.0
|
20.0 days
Interval 7.0 to 842.0
|
28.0 days
Interval 1.0 to 907.0
|
21.0 days
Interval 4.0 to 1536.0
|
58.0 days
Interval 11.0 to 101.0
|
5.0 days
Interval 4.0 to 25.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Infection
|
8.0 days
Interval 1.0 to 183.0
|
10.0 days
Interval 1.0 to 1026.0
|
9.5 days
Interval 1.0 to 546.0
|
11.5 days
Interval 1.0 to 46.0
|
8.0 days
Interval 1.0 to 85.0
|
9.0 days
Interval 2.0 to 366.0
|
9.0 days
Interval 1.0 to 281.0
|
9.5 days
Interval 1.0 to 78.0
|
9.0 days
Interval 1.0 to 39.0
|
—
|
—
|
|
Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)
Myelosuppression
|
27.0 days
Interval 6.0 to 769.0
|
22.0 days
Interval 1.0 to 1762.0
|
18.0 days
Interval 1.0 to 1541.0
|
28.0 days
Interval 13.0 to 120.0
|
15.0 days
Interval 1.0 to 336.0
|
15.0 days
Interval 2.0 to 504.0
|
11.5 days
Interval 1.0 to 889.0
|
5.0 days
Interval 1.0 to 376.0
|
7.0 days
Interval 1.0 to 43.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafterPopulation: Safety population included all participants who receive at least one dose of study medication.
Laboratory assessments included urinalysis, complete blood count (CBC), prothrombin time/partial prothromboplastin time (PT/PPT), international normalized ratio (INR), blood chemistry and serum pregnancy test (β-HCG). Parameters of special interest included liver function tests and those related to myelosuppression. Potentially clinically important (PCI) laboratory values were defined as National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher. Maximum CTCAE grade, and only participants who shifted to Grade 3/4 on-treatment, are reported.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=79 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=64 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Platelet count: shift from Normal to Grade 3
|
7.7 Percentage of Participants
|
13.3 Percentage of Participants
|
13.5 Percentage of Participants
|
0.0 Percentage of Participants
|
15.8 Percentage of Participants
|
12.0 Percentage of Participants
|
11.4 Percentage of Participants
|
4.7 Percentage of Participants
|
4.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Hemoglobin: shift from Normal to Grade 3
|
3.8 Percentage of Participants
|
0.5 Percentage of Participants
|
1.1 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
5.1 Percentage of Participants
|
1.6 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Hemoglobin: shift from Grade 2 to Grade 4
|
0.0 Percentage of Participants
|
2.1 Percentage of Participants
|
1.1 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
4.0 Percentage of Participants
|
2.5 Percentage of Participants
|
4.7 Percentage of Participants
|
4.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ANC: shift from Grade 2 to Grade 3
|
0.0 Percentage of Participants
|
1.0 Percentage of Participants
|
3.4 Percentage of Participants
|
0.0 Percentage of Participants
|
2.6 Percentage of Participants
|
2.0 Percentage of Participants
|
3.8 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ANC: shift from Grade 3 to Grade 4
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.1 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.0 Percentage of Participants
|
0.0 Percentage of Participants
|
4.7 Percentage of Participants
|
8.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Platelet count: shift from Normal to Grade 4
|
15.4 Percentage of Participants
|
3.6 Percentage of Participants
|
7.9 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
8.0 Percentage of Participants
|
7.6 Percentage of Participants
|
1.6 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Platelet count: shift from Grade 2 to Grade 3
|
0.0 Percentage of Participants
|
0.5 Percentage of Participants
|
2.2 Percentage of Participants
|
20.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.0 Percentage of Participants
|
3.8 Percentage of Participants
|
4.7 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Platelet count: shift from Grade 2 to Grade 4
|
0.0 Percentage of Participants
|
0.5 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.3 Percentage of Participants
|
4.7 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ALT: shift from Normal to Grade 3
|
15.4 Percentage of Participants
|
8.7 Percentage of Participants
|
12.4 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
10.0 Percentage of Participants
|
5.1 Percentage of Participants
|
1.6 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
AST: shift from Normal to Grade 3
|
7.7 Percentage of Participants
|
4.1 Percentage of Participants
|
7.9 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.5 Percentage of Participants
|
1.6 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ALP: shift from Grade 1 to Grade 3
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.6 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Platelet count: shift from Grade 1 to Grade 3
|
3.8 Percentage of Participants
|
3.6 Percentage of Participants
|
5.6 Percentage of Participants
|
0.0 Percentage of Participants
|
2.6 Percentage of Participants
|
2.0 Percentage of Participants
|
5.1 Percentage of Participants
|
3.1 Percentage of Participants
|
4.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Platelet count: shift from Grade 1 to Grade 4
|
0.0 Percentage of Participants
|
1.5 Percentage of Participants
|
1.1 Percentage of Participants
|
0.0 Percentage of Participants
|
2.6 Percentage of Participants
|
4.0 Percentage of Participants
|
6.3 Percentage of Participants
|
6.3 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Platelet count: shift from Grade 3 to Grade 4
|
0.0 Percentage of Participants
|
1.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.0 Percentage of Participants
|
5.1 Percentage of Participants
|
10.9 Percentage of Participants
|
29.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Hemoglobin: shift from Grade 2 to Grade 3
|
0.0 Percentage of Participants
|
3.1 Percentage of Participants
|
6.7 Percentage of Participants
|
0.0 Percentage of Participants
|
7.9 Percentage of Participants
|
0.0 Percentage of Participants
|
10.1 Percentage of Participants
|
15.6 Percentage of Participants
|
16.7 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Hemoglobin: shift from Normal to Grade 4
|
0.0 Percentage of Participants
|
1.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Hemoglobin: shift from Grade 1 to Grade 3
|
0.0 Percentage of Participants
|
3.6 Percentage of Participants
|
10.1 Percentage of Participants
|
0.0 Percentage of Participants
|
2.6 Percentage of Participants
|
0.0 Percentage of Participants
|
7.6 Percentage of Participants
|
6.3 Percentage of Participants
|
8.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Hemoglobin: shift from Grade 1 to Grade 4
|
0.0 Percentage of Participants
|
1.5 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
4.0 Percentage of Participants
|
1.3 Percentage of Participants
|
3.1 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Hemoglobin: shift from Grade 3 to Grade 4
|
0.0 Percentage of Participants
|
0.5 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
5.1 Percentage of Participants
|
4.7 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Absolute neutrophils (ANC): Normal to Grade 3
|
11.5 Percentage of Participants
|
7.2 Percentage of Participants
|
9.0 Percentage of Participants
|
0.0 Percentage of Participants
|
5.3 Percentage of Participants
|
4.0 Percentage of Participants
|
10.1 Percentage of Participants
|
3.1 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ANC: shift from Normal to Grade 4
|
3.8 Percentage of Participants
|
2.1 Percentage of Participants
|
3.4 Percentage of Participants
|
20.0 Percentage of Participants
|
7.9 Percentage of Participants
|
4.0 Percentage of Participants
|
2.5 Percentage of Participants
|
3.1 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ANC: shift from Grade 1 to Grade 3
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.2 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.5 Percentage of Participants
|
7.8 Percentage of Participants
|
12.5 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ANC: shift from Grade 1 to Grade 4
|
0.0 Percentage of Participants
|
0.5 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.6 Percentage of Participants
|
2.0 Percentage of Participants
|
1.3 Percentage of Participants
|
20.3 Percentage of Participants
|
4.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ANC: shift from Grade 2 to Grade 4
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.3 Percentage of Participants
|
3.1 Percentage of Participants
|
8.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ALT: shift from Grade 1 to Grade 3
|
0.0 Percentage of Participants
|
1.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
3.8 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
AST: shift from Normal to Grade 4
|
3.8 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
AST: shift from Grade 1 to Grade 3
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.0 Percentage of Participants
|
2.5 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ALP: shift from Normal to Grade 3
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.3 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Total bilirubin: shift from Normal to Grade 3
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.0 Percentage of Participants
|
0.0 Percentage of Participants
|
6.3 Percentage of Participants
|
4.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
ALT: shift from Normal to Grade 4
|
3.8 Percentage of Participants
|
0.0 Percentage of Participants
|
2.2 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Laboratory Tests Results
Total bilirubin: shift from Grade 2 to Grade 3
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visitPopulation: Safety population included all participants who receive at least one dose of study medication. 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure.
Criteria for PCI changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval \>=220 msec and increase of \>=20 msec; QRS interval \>=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett formula (QTcB) \>500 msec or increase of \>60 msec; heart rate \<=45 beats per minute (bpm) or \>=120 bpm or decrease/increase of \>=15 bpm.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=37 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=78 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=62 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=23 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With On-treatment PCI Change From Baseline in Electrocardiogram (ECG) Findings
|
23.1 Percentage of participants
|
32.3 Percentage of participants
|
23.6 Percentage of participants
|
20.0 Percentage of participants
|
24.3 Percentage of participants
|
22.0 Percentage of participants
|
39.7 Percentage of participants
|
59.7 Percentage of participants
|
34.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8, and end of treatmentPopulation: Safety population included all participants who received at lease one dose of study medication.
Number of participants whose chest X-ray results changed (worsened or improved) from the Baseline.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=79 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=64 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Findings of Chest X-ray
Worsened From Baseline
|
3 participants
|
35 participants
|
18 participants
|
1 participants
|
6 participants
|
18 participants
|
16 participants
|
10 participants
|
3 participants
|
—
|
—
|
|
Number of Participants With Change From Baseline in Findings of Chest X-ray
Improved From Baseline
|
3 participants
|
15 participants
|
7 participants
|
0 participants
|
4 participants
|
1 participants
|
6 participants
|
11 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Change From Baseline in Findings of Chest X-ray
Total
|
6 participants
|
50 participants
|
25 participants
|
1 participants
|
10 participants
|
19 participants
|
22 participants
|
21 participants
|
4 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 3, 4, 8, 12, then every 12 weeks thereafter until end of treatment, for a mean duration of 28 monthsPopulation: Safety population included all participants who receive at least one dose of study medication.
Number of participants taking any non-study medications which were administered from Study Day 1 to 30 days after last dose of study treatment as a management of an AE are reported.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=79 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=64 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
AST
|
4 participants
|
5 participants
|
3 participants
|
0 participants
|
2 participants
|
3 participants
|
2 participants
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Effusion
|
1 participants
|
11 participants
|
5 participants
|
1 participants
|
3 participants
|
9 participants
|
9 participants
|
2 participants
|
0 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Haemorrhage
|
1 participants
|
12 participants
|
3 participants
|
0 participants
|
1 participants
|
0 participants
|
4 participants
|
6 participants
|
3 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
ALT
|
1 participants
|
7 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Anemia
|
1 participants
|
6 participants
|
8 participants
|
2 participants
|
2 participants
|
2 participants
|
6 participants
|
1 participants
|
1 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Cardiac events
|
0 participants
|
13 participants
|
4 participants
|
0 participants
|
2 participants
|
6 participants
|
7 participants
|
2 participants
|
1 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Gastrointestinal toxicity - Diarrhoea
|
14 participants
|
120 participants
|
46 participants
|
2 participants
|
22 participants
|
26 participants
|
44 participants
|
22 participants
|
10 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Hypertension
|
1 participants
|
15 participants
|
4 participants
|
0 participants
|
2 participants
|
4 participants
|
7 participants
|
2 participants
|
2 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Hypersensitivity reactions
|
2 participants
|
5 participants
|
2 participants
|
0 participants
|
4 participants
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Infection
|
10 participants
|
92 participants
|
39 participants
|
4 participants
|
11 participants
|
18 participants
|
37 participants
|
30 participants
|
7 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Hepatic events
|
2 participants
|
10 participants
|
5 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
3 participants
|
0 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Gastrointestinal toxicity - Nausea
|
8 participants
|
33 participants
|
25 participants
|
1 participants
|
11 participants
|
10 participants
|
19 participants
|
23 participants
|
7 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Neutropenia
|
1 participants
|
2 participants
|
5 participants
|
1 participants
|
5 participants
|
1 participants
|
6 participants
|
5 participants
|
2 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Rash
|
3 participants
|
44 participants
|
37 participants
|
2 participants
|
8 participants
|
16 participants
|
20 participants
|
9 participants
|
2 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Oedema
|
0 participants
|
13 participants
|
9 participants
|
1 participants
|
3 participants
|
3 participants
|
7 participants
|
7 participants
|
3 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Renal
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
4 participants
|
3 participants
|
0 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Thrombocytopenia
|
13 participants
|
4 participants
|
2 participants
|
3 participants
|
10 participants
|
19 participants
|
3 participants
|
3 participants
|
0 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Vascular events
|
0 participants
|
6 participants
|
3 participants
|
0 participants
|
0 participants
|
3 participants
|
2 participants
|
1 participants
|
0 participants
|
—
|
—
|
|
Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)
Gastrointestinal toxicity - Vomiting
|
4 participants
|
25 participants
|
9 participants
|
0 participants
|
5 participants
|
7 participants
|
17 participants
|
14 participants
|
4 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafterPopulation: Safety population included all participants who receive at least one dose of study medication.
ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work;2=ambulatory (\>50% of waking hrs), capable of all self care, unable to carry out any work activities;3=capable of only limited self care, confined to bed/chair \>50% of waking hrs;4=completely disabled, cannot carry on any self care, totally confined to bed/chair;5=dead.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=195 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=89 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=38 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=50 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=49 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=30 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=36 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=28 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 2; maximum on-therapy: Grade 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 0; maximum on-therapy: Grade 1
|
5 participants
|
50 participants
|
25 participants
|
0 participants
|
5 participants
|
8 participants
|
11 participants
|
5 participants
|
47 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 0; maximum on-therapy: Grade 2
|
0 participants
|
3 participants
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 0; maximum on-therapy: Grade 0
|
19 participants
|
92 participants
|
36 participants
|
2 participants
|
21 participants
|
20 participants
|
17 participants
|
9 participants
|
9 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 0; maximum on-therapy: Grade 3
|
0 participants
|
4 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 0; maximum on-therapy: Grade 4
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 1; maximum on-therapy: Grade 0
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 1; maximum on-therapy: Grade 1
|
2 participants
|
32 participants
|
13 participants
|
2 participants
|
7 participants
|
13 participants
|
14 participants
|
7 participants
|
7 participants
|
5 participants
|
3 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 1; maximum on-therapy: Grade 2
|
0 participants
|
10 participants
|
6 participants
|
1 participants
|
1 participants
|
5 participants
|
2 participants
|
5 participants
|
0 participants
|
6 participants
|
3 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 1; maximum on-therapy: Grade 3
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 1; maximum on-therapy: Grade 4
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 2; maximum on-therapy: Grade 0
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 2; maximum on-therapy: Grade 2
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
6 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 2; maximum on-therapy: Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 2; maximum on-therapy: Grade 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Missing
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 0; maximum on-therapy: Missing
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Baseline: Grade 1; maximum on-therapy: Missing
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Screening, Baseline, and end of treatmentPopulation: Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of \<40 beats per min and value \>150 beats per min, systolic blood pressure (SBP) of \<80 or \>210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of \<40 or \>130 mmHg, temperature \<32 or \>40 degree centigrade, respiratory rate (Resp) of \<10 or \>50 breaths/min and criteria for PCI change in physical examination: \>=10% increase or decrease of body weight in kilogram (kg).
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=25 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=188 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=81 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=5 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=35 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=46 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=75 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=56 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=20 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs
SBP >210 mmHg
|
0 percentage of participants
|
1.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs
Weight increase 10%
|
16.0 percentage of participants
|
16.0 percentage of participants
|
6.3 percentage of participants
|
20.0 percentage of participants
|
12.1 percentage of participants
|
6.5 percentage of participants
|
11.0 percentage of participants
|
7.5 percentage of participants
|
6.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs
Weight decrease 10%
|
0 percentage of participants
|
21.9 percentage of participants
|
16.3 percentage of participants
|
0 percentage of participants
|
6.1 percentage of participants
|
15.2 percentage of participants
|
23.3 percentage of participants
|
9.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs
SBP <80 mmHg
|
4.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs
Temperature <32C
|
4.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs
Pulse <40bpm
|
0 percentage of participants
|
0 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs
Resp >50 breaths/min
|
5.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs
Resp <10 breaths/min
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-therapyPopulation: Safety population included all participants who receive at least one dose of study medication. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure. PLEASE NOTE: Results were not applicable for Arms in Part 1 since all participants in Part 1 entered Part 2 and continued the study treatment.
Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of \<40 beats per min and value \>150 beats per min, SBP of \<80 or \>210 mmHg, DBP of \<40 or \>130 mmHg, temperature \<32 or \>40 degree centigrade, Resp of \<10 or \>50 breaths/min and criteria for PCI change in physical examination: \>=10% increase or decrease of body weight in kg. No Ph+ ALL participants were analyzed post-therapy (N=0). Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
Outcome measures
| Measure |
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=4 Participants
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=24 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=16 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
n=1 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
n=2 Participants
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=11 Participants
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
Bosutinib 500 mg, AP-CML IM R/I (Part 2)
n=8 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
n=3 Participants
Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, BP-CML IM R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values
Pulse <40 bpm
|
0 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values
SBP >210 mmHg
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values
Weight increase 10%
|
0 percentage of participants
|
4.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values
Weight decrease 10%
|
0 percentage of participants
|
12.5 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
9.1 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
Adverse Events
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
Serious events: 81 serious events
Other events: 194 other events
Deaths: 0 deaths
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
Serious events: 34 serious events
Other events: 89 other events
Deaths: 0 deaths
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
Serious events: 15 serious events
Other events: 38 other events
Deaths: 0 deaths
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
Serious events: 19 serious events
Other events: 50 other events
Deaths: 0 deaths
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
AP-CML Total (Part 2)
Serious events: 43 serious events
Other events: 79 other events
Deaths: 0 deaths
BP-CML Total (Part 2)
Serious events: 37 serious events
Other events: 62 other events
Deaths: 0 deaths
Bosutinib 500 mg, Ph+ ALL (Part 2)
Serious events: 17 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
n=195 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
n=89 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
n=5 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
n=38 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
n=50 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
AP-CML Total (Part 2)
n=79 participants at risk
All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
|
BP-CML Total (Part 2)
n=64 participants at risk
All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=24 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Headache
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Syncope
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Encephalitis post varicella
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Epilepsy
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Cardiac disorder
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Psychiatric disorders
Confusional state
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Renal failure
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Haematuria
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Renal impairment
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.1%
8/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.5%
4/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.3%
5/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
5/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.7%
6/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Circumoral oedema
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Surgical and medical procedures
Allogenic bone marrow transplantation therapy
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Vascular disorders
Hypertension
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Vascular disorders
Hypotension
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Vascular disorders
Aortic stenosis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Vascular disorders
Venous thrombosis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Infection
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Leukostasis syndrome
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Congenital, familial and genetic disorders
Cytogenetic abnormality
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Adhesion
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Death
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Hepatobiliary disorders
Perforation bile duct
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Atypical pneunomia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Device related infection
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Post procedure infection
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Facial bone fracture
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Intraocular pressure increased
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system leukaemia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraproteinaemia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Cerebellar infarction
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Encephalopathy
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Parkinson's disease
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Radiculitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Psychiatric disorders
Hallucination, visual
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Psychiatric disorders
Mental status change
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Social circumstances
Pregnancy of partner
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Surgical and medical procedures
Knee anthroplasty
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.3%
5/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
16.7%
4/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Cardiac failure
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Coronary artery disease
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Pericardial effusion
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Pericarditis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Angina pectoris
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Angina unstable
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Pericardial haemorrhage
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Extrasystoles
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Pleuropericarditis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Eye disorders
Diplopia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Eye disorders
Glaucoma
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Eye disorders
Cataract
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.8%
5/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Gastritis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Haematochezia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Dysphagia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Melaena
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Proctocolitis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Pyrexia
|
2.6%
5/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.8%
5/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Chest pain
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
General physical health deterioration
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Asthenia
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Disease progression
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Chills
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Multi-organ failure
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Oedema
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Pain
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Adverse drug reaction
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Local swelling
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Malaise
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Oedema peripheral
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Submandibular mass
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Immune system disorders
Drug hypersensitivity
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pneumonia
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.6%
5/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.4%
9/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.8%
5/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
3/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Sepsis
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Septic shock
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Bronchitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Cellulitis
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Gastroenteritis viral
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Lung infection
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Sinusitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Appendicitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Cystitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Erysipelas
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Gastroenteritis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Influenza
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Kidney infection
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Meningitis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Orchitis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pharyngitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pneumonia bacterial
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pneumonia fungal
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pneumonia necrotising
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pyelonephritis acute
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Tooth abscess
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Wound haematoma
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Platelet count decreased
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood bilirubin increased
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood glucose increased
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood pressure increased
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Liver function test abnormal
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Weight decreased
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blast cell crisis
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blast crisis in myelogenous leukaemia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
Other adverse events
| Measure |
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
n=195 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
n=89 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
|
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
n=5 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
n=38 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
n=50 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
|
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
n=26 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
|
AP-CML Total (Part 2)
n=79 participants at risk
All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
|
BP-CML Total (Part 2)
n=64 participants at risk
All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
|
Bosutinib 500 mg, Ph+ ALL (Part 2)
n=24 participants at risk
Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
|
|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.1%
8/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
13.2%
5/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.3%
5/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.6%
7/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
7/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Vascular disorders
Haematoma
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
3/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
White blood cells urine positive
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.3%
61/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
36.0%
32/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
60.0%
3/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
23.7%
9/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
36.0%
18/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
46.2%
12/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
44.3%
35/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
28.1%
18/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.8%
5/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
45/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
27.0%
24/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.0%
2/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.4%
7/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.0%
7/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
23.1%
6/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
41.8%
33/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
29.7%
19/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
41.7%
10/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
26/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.6%
13/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
21.1%
8/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.0%
6/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
26.9%
7/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.2%
12/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
25.0%
16/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.7%
19/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
9.0%
8/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.5%
4/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.9%
7/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.1%
9/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.6%
7/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Diarrhoea
|
85.1%
166/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
85.4%
76/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
100.0%
5/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
78.9%
30/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
84.0%
42/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
84.6%
22/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
84.8%
67/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
64.1%
41/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
62.5%
15/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Nausea
|
43.6%
85/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
51.7%
46/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.0%
2/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
52.6%
20/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
46.0%
23/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
46.2%
12/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
45.6%
36/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
46.9%
30/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
50.0%
12/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Vomiting
|
37.4%
73/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
36.0%
32/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
36.8%
14/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
48.0%
24/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
26.9%
7/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
44.3%
35/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.6%
26/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
45.8%
11/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.6%
50/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
27.0%
24/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
21.1%
8/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
24.0%
12/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
30.8%
8/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
24.1%
19/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
17.2%
11/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
3/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
21.0%
41/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
19.1%
17/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
21.1%
8/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.0%
9/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.4%
4/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.4%
9/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.9%
7/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Constipation
|
11.3%
22/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
19.1%
17/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.0%
2/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.0%
7/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
17.7%
14/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.1%
9/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
16.7%
4/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.8%
21/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
7/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.4%
7/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.0%
4/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.4%
9/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.7%
17/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
9.0%
8/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.0%
4/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.7%
6/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.1%
8/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
9/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Pyrexia
|
29.7%
58/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
19.1%
17/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
13.2%
5/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.0%
7/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
35.4%
28/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
34.4%
22/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
41.7%
10/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Fatigue
|
25.1%
49/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
27.0%
24/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
60.0%
3/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
21.1%
8/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
24.0%
12/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
21.5%
17/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.3%
13/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.8%
5/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Asthenia
|
12.8%
25/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.0%
16/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.0%
2/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.4%
4/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
13.9%
11/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.8%
5/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Oedema peripheral
|
8.7%
17/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.4%
11/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.0%
4/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.4%
4/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.9%
7/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.8%
5/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Pain
|
8.2%
16/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.6%
5/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.0%
2/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Chest pain
|
6.7%
13/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
7/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Oedema
|
4.6%
9/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.5%
4/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.3%
5/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Chills
|
6.7%
13/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.6%
5/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
3/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Nasopharyngitis
|
12.8%
25/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.6%
13/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.4%
4/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.9%
7/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.7%
19/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
9/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.0%
2/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.0%
7/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
8/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Influenza
|
10.8%
21/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.7%
6/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.5%
4/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.0%
4/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.3%
5/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Urinary tract infection
|
10.3%
20/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
9.0%
8/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Alanine aminotransferase increased
|
21.5%
42/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
23.6%
21/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.8%
6/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.0%
6/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
19.2%
5/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
13.9%
11/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Platelet count decreased
|
8.2%
16/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.4%
11/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.3%
5/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Weight decreased
|
13.8%
27/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
9.0%
8/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.0%
7/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood creatinine increased
|
9.2%
18/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
9.0%
8/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.5%
4/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.0%
6/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.4%
4/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Lipase increased
|
8.7%
17/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
9/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.3%
5/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.9%
29/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
13.5%
12/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
14.0%
7/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.4%
4/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.9%
7/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.8%
12/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.1%
10/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.6%
5/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
9.4%
6/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
12/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.3%
5/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.7%
6/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.9%
31/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
19.1%
17/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
13.2%
5/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
10/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
23.1%
6/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.2%
12/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
8/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
3/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.3%
22/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.0%
16/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
13.2%
5/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
8/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
16.7%
4/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
27/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.5%
4/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.4%
9/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
9.4%
6/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
3/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
16/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
7/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.9%
7/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
9.4%
6/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
11/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.9%
7/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
3/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Headache
|
17.9%
35/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.2%
18/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.4%
7/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
30.0%
15/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
30.8%
8/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.2%
12/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.3%
13/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
25.0%
6/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Dizziness
|
8.2%
16/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
9/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.0%
2/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
13.2%
5/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
16.0%
8/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
13.9%
11/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.9%
7/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Psychiatric disorders
Insomnia
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
60.0%
3/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
8/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.8%
5/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Psychiatric disorders
Anxiety
|
4.1%
8/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
7/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
8/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.6%
46/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
21.3%
19/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.0%
2/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.4%
7/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
24.0%
12/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.4%
4/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
30.4%
24/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
8/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
23/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
9/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.0%
9/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
17.7%
14/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
18.8%
12/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
16.7%
4/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.8%
25/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.2%
10/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
8/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.2%
18/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
7/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
26.0%
13/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
8/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Rash
|
32.3%
63/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.4%
36/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
40.0%
2/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
26.3%
10/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
36.0%
18/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
34.2%
27/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
31.2%
20/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
16.7%
4/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.2%
18/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
9/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
23.7%
9/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
16.0%
8/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.2%
16/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.5%
4/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.0%
4/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.1%
10/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.5%
4/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Vascular disorders
Hypertension
|
8.7%
17/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.7%
6/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.0%
4/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Toothache
|
6.2%
12/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.7%
6/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.8%
5/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Bronchitis
|
6.7%
13/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Sinusitis
|
3.6%
7/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.0%
4/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Amylase increased
|
6.2%
12/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Aspartate aminotransferase increased
|
19.5%
38/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.2%
18/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.4%
4/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.2%
12/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.2%
14/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Haemoglobin decreased
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.2%
10/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Weight increased
|
6.2%
12/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
White blood cell count decreased
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.1%
9/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.1%
8/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.8%
5/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
11/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Paraesthesia
|
5.6%
11/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Psychiatric disorders
Depression
|
4.6%
9/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.5%
4/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.8%
5/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.6%
7/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
11/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Vascular disorders
Flushing
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Cardiac disorders
Tachycardia
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Ear and labyrinth disorders
Ear pain
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Eye disorders
Eye oedema
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Eye disorders
Visual acuity reduced
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.6%
5/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Gingival pain
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.6%
7/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Stomatitis
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Chest discomfort
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Face oedema
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Influenza like illness
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.6%
5/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
General disorders
Temperature intolerance
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Immune system disorders
Drug hypersensitivity
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Gingivitis
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.1%
8/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Oral candidiasis
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Oral herpes
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.6%
6/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pharyngitis
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.6%
5/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Pneumonia
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
11.5%
3/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood urea increased
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Blood uric acid increased
|
5.6%
11/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Globulins decreased
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Investigations
Neutrophil count decreased
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.6%
5/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
15.4%
4/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.2%
4/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Dysgeusia
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
3/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Somnolence
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Nervous system disorders
Syncope
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Dysuria
|
3.1%
6/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.5%
4/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
3/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Pollakiuria
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Renal failure
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.3%
5/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Renal and urinary disorders
Urinary retention
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
10.0%
5/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilum mass
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
8.3%
2/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.1%
2/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.2%
1/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.1%
4/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.3%
2/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
5/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
7/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
5.1%
4/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.6%
1/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.4%
3/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
6.0%
3/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
3.8%
1/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.7%
2/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.5%
3/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.0%
1/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.3%
1/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.7%
3/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
12.5%
3/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
1.0%
2/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
1.1%
1/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.6%
1/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Infections and infestations
Wound infection
|
0.00%
0/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.51%
1/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
7.9%
7/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.5%
2/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.6%
5/195 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
2.2%
2/89 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
20.0%
1/5 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/38 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
4.0%
2/50 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/26 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/79 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/64 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
0.00%
0/24 • Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER