Trial Outcomes & Findings for Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma (NCT NCT01011920)
NCT ID: NCT01011920
Last Updated: 2026-03-19
Results Overview
Percentage of patients with complete remission after 3 month of treatment. Percentage values are rounded to whole numbers.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
227 participants
Primary outcome timeframe
3 months after treatment start
Results posted on
2026-03-19
Participant Flow
Two hundreds and twenty seven patients were enrolled and treated in the IELSG32 study. Eight patients were excluded (five from arm B and three from arm C) because of misdiagnosis, systemic lymphoma, or concomitant cancer.
At the end of first randomization 167 patients with responsive or stable disease were observed . Eighteen patients experienced PD before the second randomization, 12 were deemed unfit, and 15 had no harvest. Consequently, 122 patients were eligible and assessable for second randomization. Four patients refused the second randomization, leaving 59 patients allocated to Arm D and 59 to Arm E. Of these, five patients refused consolidation resulting in 113 patients proceeding
Participant milestones
| Measure |
MTX + AraC
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
|
MTX + Ara-C + Rituximab
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
|
MTX + Ara-C + Rituximab+Thiotepa
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
|
WBRT 36 Gy +/- Boost 9 Gy
ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
|
BCNU + Thiotepa + APBSCT
Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
|
|---|---|---|---|---|---|
|
First Randomization
STARTED
|
75
|
69
|
75
|
0
|
0
|
|
First Randomization
COMPLETED
|
46
|
55
|
66
|
0
|
0
|
|
First Randomization
NOT COMPLETED
|
29
|
14
|
9
|
0
|
0
|
|
Second Randomization
STARTED
|
0
|
0
|
0
|
55
|
58
|
|
Second Randomization
COMPLETED
|
0
|
0
|
0
|
52
|
54
|
|
Second Randomization
NOT COMPLETED
|
0
|
0
|
0
|
3
|
4
|
Reasons for withdrawal
| Measure |
MTX + AraC
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
|
MTX + Ara-C + Rituximab
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
|
MTX + Ara-C + Rituximab+Thiotepa
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
|
WBRT 36 Gy +/- Boost 9 Gy
ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
|
BCNU + Thiotepa + APBSCT
Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
|
|---|---|---|---|---|---|
|
First Randomization
Death
|
7
|
3
|
3
|
0
|
0
|
|
First Randomization
Progressive Disease
|
22
|
11
|
6
|
0
|
0
|
|
Second Randomization
Death
|
0
|
0
|
0
|
0
|
2
|
|
Second Randomization
Progressive Disease
|
0
|
0
|
0
|
3
|
2
|
Baseline Characteristics
Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
Baseline characteristics by cohort
| Measure |
MTX + AraC
n=75 Participants
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
|
MTX + Ara-C + Rituximab
n=69 Participants
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
|
MTX + Ara-C + Rituximab+Thiotepa
n=75 Participants
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=110 Participants
|
69 Participants
n=114 Participants
|
75 Participants
n=224 Participants
|
219 Participants
n=104 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=104 Participants
|
|
Age, Continuous
|
58 years
n=110 Participants
|
57 years
n=114 Participants
|
57 years
n=224 Participants
|
57 years
n=104 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=110 Participants
|
25 Participants
n=114 Participants
|
29 Participants
n=224 Participants
|
83 Participants
n=104 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=110 Participants
|
44 Participants
n=114 Participants
|
46 Participants
n=224 Participants
|
136 Participants
n=104 Participants
|
|
Region of Enrollment
Denmark
|
6 participants
n=110 Participants
|
0 participants
n=114 Participants
|
5 participants
n=224 Participants
|
11 participants
n=104 Participants
|
|
Region of Enrollment
Italy
|
29 participants
n=110 Participants
|
29 participants
n=114 Participants
|
34 participants
n=224 Participants
|
92 participants
n=104 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=110 Participants
|
18 participants
n=114 Participants
|
14 participants
n=224 Participants
|
39 participants
n=104 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=110 Participants
|
1 participants
n=114 Participants
|
0 participants
n=224 Participants
|
2 participants
n=104 Participants
|
|
Region of Enrollment
Germany
|
32 participants
n=110 Participants
|
21 participants
n=114 Participants
|
22 participants
n=224 Participants
|
75 participants
n=104 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
ECOG 0-1
|
48 Participants
n=110 Participants
|
46 Participants
n=114 Participants
|
51 Participants
n=224 Participants
|
145 Participants
n=104 Participants
|
|
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
ECOG>1
|
27 Participants
n=110 Participants
|
23 Participants
n=114 Participants
|
24 Participants
n=224 Participants
|
74 Participants
n=104 Participants
|
|
Meningeal involvement
No meningeal involvement
|
45 Participants
n=110 Participants
|
43 Participants
n=114 Participants
|
40 Participants
n=224 Participants
|
128 Participants
n=104 Participants
|
|
Increased LDH
Increased LDH
|
37 Participants
n=110 Participants
|
26 Participants
n=114 Participants
|
25 Participants
n=224 Participants
|
88 Participants
n=104 Participants
|
|
Increased LDH
No increased LDH
|
38 Participants
n=110 Participants
|
43 Participants
n=114 Participants
|
50 Participants
n=224 Participants
|
131 Participants
n=104 Participants
|
|
Deep lesions
Deep lesions
|
58 Participants
n=110 Participants
|
52 Participants
n=114 Participants
|
64 Participants
n=224 Participants
|
174 Participants
n=104 Participants
|
|
Deep lesions
No deep lesions
|
17 Participants
n=110 Participants
|
17 Participants
n=114 Participants
|
11 Participants
n=224 Participants
|
45 Participants
n=104 Participants
|
|
Increased cerebrospinal fluid (CSF) protein
Increased CSF protein
|
33 Participants
n=110 Participants
|
33 Participants
n=114 Participants
|
35 Participants
n=224 Participants
|
101 Participants
n=104 Participants
|
|
Increased cerebrospinal fluid (CSF) protein
No increased CSF protein
|
23 Participants
n=110 Participants
|
20 Participants
n=114 Participants
|
18 Participants
n=224 Participants
|
61 Participants
n=104 Participants
|
|
Increased cerebrospinal fluid (CSF) protein
Not recorded
|
19 Participants
n=110 Participants
|
16 Participants
n=114 Participants
|
22 Participants
n=224 Participants
|
57 Participants
n=104 Participants
|
|
International Extranodal Lymphoma Study Group (IELSG) risk score
Low Risk
|
14 Participants
n=110 Participants
|
12 Participants
n=114 Participants
|
13 Participants
n=224 Participants
|
39 Participants
n=104 Participants
|
|
Meningeal involvement
Not recorded
|
19 Participants
n=110 Participants
|
16 Participants
n=114 Participants
|
22 Participants
n=224 Participants
|
57 Participants
n=104 Participants
|
|
International Extranodal Lymphoma Study Group (IELSG) risk score
Intermediate Risk
|
47 Participants
n=110 Participants
|
44 Participants
n=114 Participants
|
47 Participants
n=224 Participants
|
138 Participants
n=104 Participants
|
|
International Extranodal Lymphoma Study Group (IELSG) risk score
High Risk
|
14 Participants
n=110 Participants
|
13 Participants
n=114 Participants
|
15 Participants
n=224 Participants
|
42 Participants
n=104 Participants
|
|
Intraocular disease
Intraocular disease
|
5 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
7 Participants
n=104 Participants
|
|
Intraocular disease
No intraocular disease
|
70 Participants
n=110 Participants
|
68 Participants
n=114 Participants
|
74 Participants
n=224 Participants
|
212 Participants
n=104 Participants
|
|
Meningeal involvement
Meningeal involvement
|
11 Participants
n=110 Participants
|
10 Participants
n=114 Participants
|
13 Participants
n=224 Participants
|
34 Participants
n=104 Participants
|
|
Multiple lesions
Multiple lesions
|
45 Participants
n=110 Participants
|
40 Participants
n=114 Participants
|
41 Participants
n=224 Participants
|
126 Participants
n=104 Participants
|
|
Multiple lesions
No multiple lesions
|
30 Participants
n=110 Participants
|
29 Participants
n=114 Participants
|
34 Participants
n=224 Participants
|
93 Participants
n=104 Participants
|
PRIMARY outcome
Timeframe: 3 months after treatment startPercentage of patients with complete remission after 3 month of treatment. Percentage values are rounded to whole numbers.
Outcome measures
| Measure |
Arm B / MTX + Ara-C + Rituximab
n=69 Participants
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
|
Arm A / MTX + AraC
n=75 Participants
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
|
Arm C / MTX + Ara-C + Rituximab+Thiotepa
n=75 Participants
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
|
Arm D / WBRT 36 Gy +/- Boost 9 Gy
ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
|
Arm E / BCNU + Thiotepa + APBSCT
Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
|
|---|---|---|---|---|---|
|
Complete Remission Rate After Primary Chemotherapy
|
30 Percentage of participants
Interval 21.0 to 42.0
|
23 Percentage of participants
Interval 14.0 to 31.0
|
49 Percentage of participants
Interval 38.0 to 60.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entryPercentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry. Percentage values are rounded to whole numbers.
Outcome measures
| Measure |
Arm B / MTX + Ara-C + Rituximab
n=58 Participants
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
|
Arm A / MTX + AraC
n=55 Participants
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
|
Arm C / MTX + Ara-C + Rituximab+Thiotepa
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
|
Arm D / WBRT 36 Gy +/- Boost 9 Gy
ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
|
Arm E / BCNU + Thiotepa + APBSCT
Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
|
|---|---|---|---|---|---|
|
2 Years Failure Free Survival (FFS) After Second Randomization
|
75 Percentage of participants
Interval 64.0 to 86.0
|
76 Percentage of participants
Interval 65.0 to 87.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entryPercentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry any cause. Percentage values are rounded to whole numbers.
Outcome measures
| Measure |
Arm B / MTX + Ara-C + Rituximab
n=69 Participants
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
|
Arm A / MTX + AraC
n=75 Participants
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
|
Arm C / MTX + Ara-C + Rituximab+Thiotepa
n=75 Participants
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
|
Arm D / WBRT 36 Gy +/- Boost 9 Gy
ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
|
Arm E / BCNU + Thiotepa + APBSCT
Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
|
|---|---|---|---|---|---|
|
2 Years Failure Free Survival (FFS)
|
46 percentage of participants
Interval 40.0 to 52.0
|
36 percentage of participants
Interval 31.0 to 41.0
|
61 percentage of participants
Interval 55.0 to 67.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry until 2 years afterPercentage of patients alive after 2 years from study entry. Percentage values are rounded to whole numbers.
Outcome measures
| Measure |
Arm B / MTX + Ara-C + Rituximab
n=69 Participants
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
|
Arm A / MTX + AraC
n=75 Participants
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
|
Arm C / MTX + Ara-C + Rituximab+Thiotepa
n=75 Participants
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
|
Arm D / WBRT 36 Gy +/- Boost 9 Gy
n=55 Participants
ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
|
Arm E / BCNU + Thiotepa + APBSCT
n=58 Participants
Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
|
|---|---|---|---|---|---|
|
2 Year Overall Survival (OS)
|
56 percentage of participants
Interval 50.0 to 62.0
|
42 percentage of participants
Interval 36.0 to 48.0
|
69 percentage of participants
Interval 64.0 to 74.0
|
76 percentage of participants
Interval 65.0 to 87.0
|
75 percentage of participants
Interval 64.0 to 86.0
|
Adverse Events
Arm A / MTX + AraC
Serious events: 39 serious events
Other events: 75 other events
Deaths: 56 deaths
Arm B / MTX + Ara-C + Rituximab
Serious events: 38 serious events
Other events: 68 other events
Deaths: 41 deaths
Arm C / MTX + Ara-C + Rituximab+Thiotepa
Serious events: 39 serious events
Other events: 74 other events
Deaths: 33 deaths
Arm D / WBRT 36 Gy +/- Boost 9 Gy
Serious events: 5 serious events
Other events: 38 other events
Deaths: 30 deaths
Arm E / BCNU + Thiotepa + APBSCT
Serious events: 10 serious events
Other events: 49 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Arm A / MTX + AraC
n=75 participants at risk
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
|
Arm B / MTX + Ara-C + Rituximab
n=69 participants at risk
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
|
Arm C / MTX + Ara-C + Rituximab+Thiotepa
n=75 participants at risk
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
|
Arm D / WBRT 36 Gy +/- Boost 9 Gy
n=55 participants at risk
ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
|
Arm E / BCNU + Thiotepa + APBSCT
n=58 participants at risk
Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
|
|---|---|---|---|---|---|
|
Vascular disorders
Epistaxis
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Vascular disorders
Embolism
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Vascular disorders
Peripheral arterial ischemia
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Vascular disorders
Hemorrhage, CNS
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Vascular disorders
Hemorrhage Pulmonary
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.7%
1/58 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Fever
|
8.0%
6/75 • Number of events 6 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
5.3%
4/75 • Number of events 4 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.8%
1/55 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Pain general
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
2.9%
2/69 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Pain abdomen
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Headache
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Lower extremity gait
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Mulri-organ failure
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Pelvic pain
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Sudden death
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Disease Progression
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Immune system disorders
Allergy
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory increase
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
3/75 • Number of events 3 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
2.7%
2/75 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Psychiatric disorders
Mood alteration
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.7%
1/58 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Psychiatric disorders
Confusion
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Cerebrovascular ischemia
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
2.9%
2/69 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Seizure
|
2.7%
2/75 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
5.8%
4/69 • Number of events 5 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.7%
1/58 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Cerebellar toxicity
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
2.9%
2/69 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Syncope
|
2.7%
2/75 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Sensory neuropathy
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
2.9%
2/69 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
3.4%
2/58 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
3.4%
2/58 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.7%
1/58 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.8%
1/55 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Perforation
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Renal and urinary disorders
Renal failure
|
2.7%
2/75 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
4.3%
3/69 • Number of events 3 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.8%
1/55 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.8%
1/55 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
2.7%
2/75 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Febrile neutropenia
|
10.7%
8/75 • Number of events 8 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
11.6%
8/69 • Number of events 8 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
21.3%
16/75 • Number of events 22 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.8%
1/55 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Viral Encephalitis
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Sepsis
|
16.0%
12/75 • Number of events 12 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
7.2%
5/69 • Number of events 5 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
6.7%
5/75 • Number of events 5 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
5.2%
3/58 • Number of events 3 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Pneumonia
|
6.7%
5/75 • Number of events 5 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
8.7%
6/69 • Number of events 7 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
10.7%
8/75 • Number of events 8 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Aspergillosis
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Infections general
|
12.0%
9/75 • Number of events 9 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
10.1%
7/69 • Number of events 10 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
20.0%
15/75 • Number of events 16 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
2.7%
2/75 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.8%
1/55 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.7%
1/58 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
2.7%
2/75 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Cholangitis
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.7%
1/58 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Gastrointestinal infections
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Metabolism and nutrition disorders
ALT increased
|
4.0%
3/75 • Number of events 4 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.3%
1/75 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.4%
1/69 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.3%
1/75 • Number of events 3 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
Other adverse events
| Measure |
Arm A / MTX + AraC
n=75 participants at risk
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
|
Arm B / MTX + Ara-C + Rituximab
n=69 participants at risk
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
|
Arm C / MTX + Ara-C + Rituximab+Thiotepa
n=75 participants at risk
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
|
Arm D / WBRT 36 Gy +/- Boost 9 Gy
n=55 participants at risk
ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
radiotherapy: Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
|
Arm E / BCNU + Thiotepa + APBSCT
n=58 participants at risk
Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0
Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
BCNU: BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
APBSCT: Autologous peripheral blood stem cell transplant (APBSCT)
|
|---|---|---|---|---|---|
|
Vascular disorders
Coagulation disorders
|
12.0%
9/75 • Number of events 16 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
15.9%
11/69 • Number of events 18 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
9.3%
7/75 • Number of events 11 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
9.1%
5/55 • Number of events 5 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
12.1%
7/58 • Number of events 7 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Nervous system disorders
Neurological toxicity
|
17.3%
13/75 • Number of events 34 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
26.1%
18/69 • Number of events 38 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
17.3%
13/75 • Number of events 27 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
18.2%
10/55 • Number of events 10 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
6.9%
4/58 • Number of events 4 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Blood and lymphatic system disorders
Anaemia
|
88.0%
66/75 • Number of events 187 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
94.2%
65/69 • Number of events 207 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
94.7%
71/75 • Number of events 261 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
16.4%
9/55 • Number of events 9 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
69.0%
40/58 • Number of events 40 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Blood and lymphatic system disorders
Neutropenia
|
90.7%
68/75 • Number of events 129 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
94.2%
65/69 • Number of events 158 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
92.0%
69/75 • Number of events 198 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
12.7%
7/55 • Number of events 7 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
84.5%
49/58 • Number of events 58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Fatigue
|
5.3%
4/75 • Number of events 5 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
10.9%
6/55 • Number of events 6 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
89.3%
67/75 • Number of events 177 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
94.2%
65/69 • Number of events 203 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
93.3%
70/75 • Number of events 248 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
3.6%
2/55 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
84.5%
49/58 • Number of events 58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Pain
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
4.0%
3/75 • Number of events 6 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
6.9%
4/58 • Number of events 4 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
General disorders
Fever
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
6.9%
4/58 • Number of events 4 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
2.9%
2/69 • Number of events 6 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
9.3%
7/75 • Number of events 10 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Ear and labyrinth disorders
Hearing impairment
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
7.3%
4/55 • Number of events 4 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.3%
13/75 • Number of events 16 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
31.9%
22/69 • Number of events 44 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
40.0%
30/75 • Number of events 30 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
1.8%
1/55 • Number of events 1 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
32.8%
19/58 • Number of events 19 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
17.3%
13/75 • Number of events 20 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
42.0%
29/69 • Number of events 68 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
40.0%
30/75 • Number of events 61 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
12.7%
7/55 • Number of events 7 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
27.6%
16/58 • Number of events 16 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Gastrointestinal disorders
Stomatitis/Mucositis
|
24.0%
18/75 • Number of events 23 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
29.0%
20/69 • Number of events 41 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
26.7%
20/75 • Number of events 46 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
3.6%
2/55 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
51.7%
30/58 • Number of events 30 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
54.7%
41/75 • Number of events 97 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
60.9%
42/69 • Number of events 104 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
52.0%
39/75 • Number of events 97 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
7.3%
4/55 • Number of events 4 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
32.8%
19/58 • Number of events 19 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.0%
18/75 • Number of events 18 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
31.9%
22/69 • Number of events 22 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
37.3%
28/75 • Number of events 28 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
29.1%
16/55 • Number of events 16 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
29.3%
17/58 • Number of events 17 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Skin and subcutaneous tissue disorders
Erithema
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/69 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/75 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
12.7%
7/55 • Number of events 7 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/58 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Infections and infestations
Infections
|
29.3%
22/75 • Number of events 22 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
26.1%
18/69 • Number of events 18 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
37.3%
28/75 • Number of events 32 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
0.00%
0/55 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
22.4%
13/58 • Number of events 13 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
|
Renal and urinary disorders
Nephrotoxicity
|
18.7%
14/75 • Number of events 31 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
26.1%
18/69 • Number of events 35 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
14.7%
11/75 • Number of events 20 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
3.6%
2/55 • Number of events 2 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
10.3%
6/58 • Number of events 6 • The AE/SAE reporting period began with the signing of the informed consent and ended 30 days after the last dose of the study drug (4 months). Deaths occurring later were only to be considered as SAE if they are related to the protocol treatments and had occurred within 6 months after the last dose.
All AEs/SAEs that occurred in patients during the reporting period had to be reported to the Sponsor, regardless of whether the event was considered to be related to the study medication or not. In addition, any known SAE suspected to be related to the study treatment that occurred after the defined reporting period had to be reported to the Sponsor. All cause mortality was assessed through 10 years after study entry.
|
Additional Information
Scientific and Medical Director
International Extranodal Lymphoma Study Group (IELSG)
Phone: +41 58 666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place